Denali Therapeutics Jobs

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Payroll Manager will report into the Associate Director, Payroll and is responsible for ensuring accurate and timely processing of payroll. This role involves handling payroll-related inquiries, maintaining payroll records, and ensuring compliance with federal, state, and local tax laws. The Payroll Manager will also assist with various payroll-related audits and reporting, providing support to the HR and Finance departments as needed. Key Accountabilities/Core Job Responsibilities: Process payrolls for all hourly and salary US employees on a bi-weekly/semi-monthly basis using Workday payroll system, ensuring process conforms to all internal SOX controls. Process all off-cycle payrolls for stock transactions and termination events timely and accurately. Validate all employee changes (ex. new hires, promotions, compensation changes, terminations) impacting payroll to ensure accuracy and proper approvals. Oversight of bi-weekly timekeeping, including weekly monitoring and resolution of timekeeping errors, ensuring employee submission and manager approvals for bi-weekly payroll processing. Perform timekeeping corrections, as needed, when managers are out of office. Prepare or assist with various payroll and tax reconciliations, internal and external audits and year-end payroll activities including W2 preparation. Ensure compliance with federal, state, and local payroll tax laws and regulations. Including staying updated on changes to payroll laws and regulations. Educate employees on payroll-related policies and procedures and resolve employee inquiries regarding payroll, deductions and other related matters. Qualifications/Skills: Bachelor's degree in accounting, finance, business administration, or a related field. 3+ years of experience in payroll processing; 1-2 years of experience with the Workday payroll module is preferred. Knowledge of payroll laws, regulations, and best practices. Strong analytical and problem-solving skills. Excellent attention to detail and accuracy. Proficiency in Microsoft Office Suite, particularly Excel. Strong communication and interpersonal skills. Ability to handle sensitive and confidential information with discretion. Salary Range: $121,000.00 to $153,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Intern, Technology Projects & Operations Center (TPOC) Address: 45 Sidney Street Cambridge, MA, 02139 Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors. Responsibilities: As an intern at our company, you will have the opportunity to contribute to various technology projects, assist with business analysis, and manage general tasks. This role is perfect for someone who is eager to learn and grow in a fast-paced environment. If you enjoy working on diverse projects and want to gain hands-on experience, this could be the opportunity for you! Projects will be crafted along one or multiple of the following key areas based on interest and business needs: * Assist with the implementation of technology projects throughout all phases, including concept, design, implementation, and operation. * Support business analysis activities, including gathering and documenting requirements, analyzing data, and creating reports. * Help manage general tasks, such as scheduling meetings, preparing presentations, and coordinating with different departments. * Interface effectively with project stakeholders, including business owners, IT teams, and vendors. * Participate in project meetings and contribute to discussions and decision-making processes. * Assist in the preparation, review, and approval of project documentation. * Collaborate with team members to ensure successful and timely project execution. * Support team with identifying and implementing process improvements * Assist in the development of SharePoint Hub sites * Support IS Trainer with training materials and recordings * Perform other duties as assigned. Qualifications: * Currently pursuing a bachelor's or master's degree in a related field (e.g., Information Technology, Business Administration, Computer Science or Project Management). * Strong interest in technology project management and business analysis. * Excellent organizational and time management skills. * Strong interpersonal and communication skills. * Ability to work in a team environment and collaborate effectively with others. What additional qualifications will make you a stronger candidate? * Previous internship or work experience in a related field. * Familiarity with project management tools and methodologies. * Basic understanding of business analysis techniques and tools. * Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). * Commitment to our core values: Innovation, Collaboration, Integrity, and Excellence. * Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism Our Summer Internship Program: Blueprint's summer internship program is ~12 weeks long. The program is designed to provide students with deep functional expertise within their department and a broad understanding of the life sciences industry. Interns are paired with dedicated mentors for personalized learning and career development guidance. The program includes lunch and learn sessions, networking events, an intern volunteer day, and other networking opportunities. It culminates in a final poster presentation where interns showcase their work. On-site Expectations and Working Hours: This is a hybrid role with flexibility to occasionally work from home. We do find that students get the most from our summer internship program by being in our offices and encourage students to work in person as much as possible. Most internship learning & networking events are only offered in person. * On-site Expectations: The expectation for this role is that the intern will be on-site at 45 Sidney Street, Cambridge MA at least 3 days per week. * Working Hours: Expected working hours for this role are 8:30AM-5:00PM Monday-Friday, with flexibility at manager discretion as needed. Dress Code: Blueprint's offices are a business casual environment. Business casual means attire that is professional but also relaxed, such as slacks or business dress pants, skirts/dresses, khakis, chinos, or dark jeans without holes paired with button-down shirts, sweaters, blouses, or polo shirts and closed-toed shoes. It typically excludes formal suits or very casual clothing such as athletic wear or flip flops. Summer Internship Program Dates: Tuesday, May 27th - Friday, August 15th Pay Range: Our summer internships are paid hourly based on class year. The expected pay range for this role is $23.00-$25.00 per hour. Why Blueprint? At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators - the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Key Accountabilities/ Core Job Responsibilities: Support supplier qualification and conduct quality audits for Denali sites including CDMOs/CTLs Supports tracking/reporting departmental metrics for Quality Systems Management Reviews Supports Quality Systems and Operations, including document control, change controls, deviations, CAPAs, effectiveness checks and temperature excursions. Writes changes to controlled documents (SOPs, Work Instructions, Specifications, etc.) as needed Responsible for ensuring compliance to cGMPs per regulations Makes improvement in Quality processes and systems Supports efforts to implement and utilize the internal electronic document management system. Supports Quality review of IND/IMPD/BLA/NDA Supports and participates in regulatory body inspection readiness May interface with regulatory agencies as required. Qualifications/Skills: BS in a scientific discipline with 5+ years of cGMP experience in Pharmaceutical Quality Assurance Current and strong working knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH Quality and development guidelines. Experience with electronic Quality Management Systems. Driven, results-oriented self-starter and excellent team player. Excellent verbal and written communication skills. Creative and pragmatic approach to problem solving and issue resolution. Maintain a strong attention to detail. Ability to closely follow Quality Standards and company Quality expectations Committed to Denali values of growth, unity, grit, and trust; as well as values related to accountability, transparency, and scientific rigor Salary Range: $113,000.00 to $135,667.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking a highly skilled Director of Safety Science to lead clinical and post-marketing safety surveillance, ensuring patient safety and regulatory compliance. This role directs safety signal and risk management activities, oversees adverse event reporting, and provides safety input for clinical and regulatory documents. Responsibilities include preparing global risk management plans, safety regulatory submissions (e.g., DSURs, PADERs), and supporting regulatory interactions, audits, and inspections. The position represents Drug Safety in internal and external meetings, tracks safety-related decisions, and maintains standard operating procedures (SOPs) to uphold best practices in pharmacovigilance. Key Accountabilities/Core Job Responsibilities: * Responsible for the strategy and implementation of the program-specific clinical and post-marketing safety surveillance to ensure patient safety and regulatory compliance. * Leads Safety Management Team(s) and directs all safety signal and risk management activities for assigned products. * Contributes to review of adverse event reports to ensure the accuracy, integrity and completeness of information. * Provide safety input to protocols, statistical analysis plans, clinical study reports, investigator's brochure, reference safety information, informed consent documents, and other clinical regulatory documents; prepare/review safety sections of new drug applications and other regulatory filings. * Ensures local and global risk management plan preparation and execution throughout a product's lifecycle. * Responsible for the completion of safety regulatory submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide. * Tracks implementation of SMT and DSC decisions. * Support responses to questions from regulatory authorities, regulatory agency audits and inspections, corrective action plans, and PV vendor oversight in collaboration with Safety Operations. * Represents Drug Safety at internal (e.g. governance and leadership teams) and external meetings (e.g. regulatory authority), attending cross-functional or project-specific team meetings to provide safety expertise, as needed. * Drafts and maintains standard work practice documents including standard operating procedures (SOPs), work instructions, forms and templates. * Performs other tasks and assignments as needed. Qualifications/Skills: * Advanced degree in health and related fields required. * At or near 10 years of relevant work experience to include 7+ years in drug safety and pharmacovigilance and a track record of successful deliveries of core safety/PV activities in cross-functional safety teams. * Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines. * Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics. * Willingness to teach and to learn. Salary Range: $213,000.00 to $265,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior MSL is a field-based representative of the medical affairs team, primarily responsible for advancing scientific and collaborative relationships with key healthcare providers (HCPs) and decision makers within a defined geography via timely knowledge exchange of accurate, scientific, and non-promotional information to enable optimized patient outcomes. Key Accountabilities/Core Job Responsibilities: Identify and develop strong scientific relationships with HCPs within a defined territory and provide credible, and fair-balanced information about Denali's research activities and product development Respond to unsolicited medical and scientific requests for medical information in a compliant and timely manner Provide clinical trial support to identify potential new sites, resolve issues with enrolling sites, and participate in investigator meetings, as appropriate; liaise with R&D, Medical Affairs, and Clinical Operations teams Provide scientific presentations at company sponsored and external meetings, as needed Develop and maintain a high level of therapeutic area, disease state and product expertise Participate in national and regional medical/scientific meetings and symposia to engage with attendees, attend scientific sessions and poster presentations, and gather clinical and business insights to share with internal cross-functional teams. Lead and/or participate in training, and other internal efforts to support medical objectives; may serve as a training lead Appropriately document interactions and act in accordance with company policies and guidelines Qualifications/Skills: Doctorate level degree is required (PharmD or PhD); MD degree preferred Specialty training in rare disease and/or neuroscience preferred 5+ years of relevant work experience, including 3+ years in an MSL role in the in the pharmaceutical/biotech industry Knowledge of current regulatory guidelines to ensure corporate compliance in all activities, including those related to scientific interactions, unsolicited questions and clinical trials and research. Excellent interpersonal and communication skills with the ability to effectively present scientific and medical information to diverse audiences, including HCPs, researchers, payors, patients and industry colleagues. Ability and willingness to travel up to 75% including overnight travel to accomplish field scientific responsibilities. This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and their contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. Summary/Job Purpose: Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company's functional areas. The candidate will perform audits of service providers, study sites, and internal processes. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Company's clinical stakeholders and act as a catalyst for continuous process improvement. Responsibilities * Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws. * Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements. * Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. * Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI). * Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines. * Quality Management System (QMS): Maintain and enhance Caribou's QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle. * Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders. * Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation. * Build training and approve curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to pre-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures. * Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management. * Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers. * Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines. * Lead and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve. Key Qualifications * Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred. * Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research. * Proven track record in developing and implementing quality systems and processes in a clinical setting. * Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits. * Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards. * Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance. * The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills. * Conscientiously detail-oriented and organized, impeccable attention to data review. * Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways. * Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. * Detail-oriented mindset with a proactive approach to problem-solving and decision-making. * Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable. Caribou compensation and benefits include: * Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees * Salary Range: $200,000 to $225,000 - This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance. * Generous paid vacation time, in addition to company-observed holidays and floating holidays * Excellent medical, dental, and vision insurance * 401(k) retirement savings plan, which includes matching employer contributions * Employee stock purchase plan (ESPP) * Tuition reimbursement program The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, hair texture of type, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc.for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee. #LI-Hybrid #LI-CC1

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position is required to be based in San Francisco, CA. Key Accountabilities/Core Job Responsibilities Legal Compliance: Advise on employment laws applicable to Denali's California, Utah, and Switzerland offices and remote employees, including wage and hour regulations, anti-discrimination laws, and leave policies. Policy Development: Draft, review, and update employee handbooks, workplace policies, and SOPs to ensure compliance and alignment with Denali culture. Employee Relations: Partner with HR to provide guidance on complex employee relations issues, investigations, and performance management. Litigation and Risk Management: Manage and oversee the resolution of employment-related disputes and coordinate responses to agencies. Hiring and Onboarding: Support the development of compliant hiring practices, offer letters, and onboarding materials. Training: Develop and deliver training programs for managers and employees on employment law topics, including performance feedback, leave policies, and workplace conduct. Immigration Oversight: Oversee and support immigration matters, manage relationships with immigration counsel, and ensure timely and efficient outcomes. Cross-Functional Support: Collaborate with teams on employment-related aspects of business strategies, including international expansion and benefits. Support the establishment of a strong, integrated culture across sites. Skills/Qualifications: J.D. degree from an accredited law school. Active California bar membership in good standing. 7+ years of relevant work experience. Expertise in U.S. federal, state, and local employment laws and regulations required; familiarity with Swiss employment law preferred. Proven experience advising on employee relations, policy development, and compliance. Experience in the biotech, life sciences, or technology sectors preferred. Strong project management skills and ability to prioritize in a fast-paced environment. Exceptional verbal and written communication skills, the ability to communicate with tact and diplomacy, and a deep, abiding sense of compassion and integrity. Growth mindset, with a willingness to learn new things, expand outside boundaries, and broaden areas of expertise. No task is too big or too small. Ability to thrive efficiently in a fast-paced environment, managing a heavy workload at times and adapting quickly to change. Excellent judgment, complemented by an awareness of when to seek guidance and collaboration. Willingness to courageously and clearly identify risks and seek solutions. A proven record of building trust and credibility through consistent and reliable partnerships with business functions. Salary Range: $225,000.00 to $272,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Key Accountabilities/Core Job Responsibilities: Serve as a data management expert and be the CDM lead for assigned clinical studies on multidisciplinary project teams. Deliver high quality data for analysis and study milestones Reviews protocols from a CDM perspective and provide functional-expert feedback Review and approve key clinical data management deliverables generated by a DM vendor, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data review plans, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, data transfer specifications, and electronic data transfer specifications Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data Collaborate with internal Data Science (statistical programming), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into DM vendor activities Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and Denali project team Monitor vendor performance to ensure timelines and data quality standards are met Ensure compliance of clinical data management processes with applicable regulations and guidelines Lead direct report(s), if applicable, through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: BA/BS or higher preferably in math, science or health-related field with a minimum of 5+ years of experience in clinical data management across phase 1- 3 clinical trials At least 5 years of the overall experience acting as a study lead data manager. Experience on all study phases including early phase, dose escalation studies is greatly preferred Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors Clear verbal and written communication skills, strong analytical and problem-solving skills. Salary Range: $135,000.00 to $166,667.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Reporting to a Principal Scientist, the Scientist will perform translational research working cross-functionally with in vivo and in vitro scientists to investigate mechanisms of neurodegeneration and advance therapeutic development. Key Accountabilities/Core Job Responsibilities: Perform research in a dynamic and collaborative environment Develop and conduct primary CNS cell and/or iPSC-based experiments to investigate effects of therapeutic candidates on CNS-relevant cellular functions Investigate mechanisms of action of therapeutic candidates, focusing on immunometabolism, lipid biology and disease relevant mechanisms Collaborate with in vivo sciences group to evaluate therapeutic candidates in neurodegenerative mouse models, including Alzheimer's disease models Make detailed scientific observations, analyze data, interpret and present results Serve on large molecule project teams throughout lead/candidate identification and IND-enabling phases to enable project decision making Contribute to patents and publications Qualifications/Skills: Ph.D. in Biochemistry, Cell Biology or Neurobiology required, postdoc or industry experience in glial and/or neuronal cell biology is preferred Proficiency in a broad range of biochemical, molecular and cellular techniques including: Western blotting, qPCR, transfection, RNA interference, immunofluorescence, live imaging techniques, and quantitative image analysis Expertise in the culture of mammalian cell lines, primary CNS cells, and/or iPSC-derived CNS cells Experience in the field of immunometabolism or lipid metabolism is highly desired Experience designing and carrying out in vivo experiments (study design, dosing strategy, brain tissue collection, immunohistochemistry) is highly desired Highly organized with excellent analytical and critical thinking skills Strong oral/written communication skills Creative and inquisitive thinker who is eager to explore and learn new skills Salary Range: $142,000.00 to $174,333.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Senior Manager office-based, in alignment with BlueFlex model Reporting Line: Country Manager and Commercial Lead Italy How will your role help us transform hope into reality? We are seeking a highly motivated and entrepreneurial Senior Manager, Brand and Commercial Excellence to lead brand strategy, optimize sales force performance, and support local market access initiatives. This role requires a blend of marketing expertise, sales force excellence, forecasting & operational planning, performance analysis, and leadership through influence to drive brand success in a competitive environment. Reporting into the Country Manager and Commercial Lead Italy, the ideal candidate will be strategic yet hands-on, comfortable navigating ambiguity, and passionate about making a difference in patients' lives. What will you do? Develop and implement brand strategies and tactical plans, aligning with global, international and regional teams Lead omnichannel and digital marketing initiatives to enhance HCP engagement and brand awareness. Monitor and adapt marketing activities based on market dynamics, competitor intelligence, and customer insights. Ensure effective budget management, tracking ROI and adjusting resource allocation as needed. Analyze sales data and performance metrics to generate actionable insights that drive brand and commercial strategy. Optimize territory performance, identify trends, and address gaps. Develop and track commercial KPIs, leveraging data-driven insights to improve sales force execution. Support territory and segmentation analysis to refine targeting strategies and improve field effectiveness. Develop and maintain accurate short-term and long-range forecasts using advanced models to support strategic planning. Collaborate with supply chain teams to ensure supply forecasts are aligned with demand fluctuations and evolving market conditions. Provide data-driven insights to anticipate trends, mitigate risks, and optimize inventory management in a rare disease setting. Design and execute sales force training programs, ensuring clear communication of brand value propositions. Optimize sales team performance by implementing best-in-class tools, analytics, and engagement strategies. Act as a strategic partner to sales teams, fostering leadership through influence rather than direct authority. Collaborate with local market access teams to ensure alignment of brand strategies with payer needs Support the development of value propositions, pricing strategies, and reimbursement initiatives. Maintain field presence, engaging with KOLs, external partners, and sales teams to stay connected to market realities. Collect and analyze competitor intelligence, identifying opportunities and risks for the brand. Work closely with Medical, , Sales, Market Access, Supply Chain, and International Marketing and Comercial Operations teams. Identify and act on new opportunities to enhance brand positioning and commercial impact. Foster a culture of agility, ownership, and strategic problem-solving within the team. What minimum qualifications do we require? Bachelor's degree. MBA preferred. 5+ years of experience in marketing, digital and commercial excellence in biotech/pharma. Experience in sales and other field roles preferred. Strong understanding of Italian pharmaceutical environment and specialty care. Proven track record in brand strategy and execution, omnichannel marketing, forecasting, and sales force optimization. Proven track record in successful product launches in specialty care and opening new markets. What additional qualifications will make you a stronger candidate? Experience working in cross-functional and highly collaborative environments and in matrix organizations. Ability to lead through influence and drive results without direct authority. Strong analytical skills, with experience in sales performance analysis, forecasting models, long-range planning (LROP), and supply chain interaction. Entrepreneurial mindset with a hands-on approach and ability to adapt to fast-changing market conditions. Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism Why Blueprint? At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators - the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success. This is the place where the extraordinary becomes reality, and you could be part of it. Patients are waiting. Are you ready to make the leap? Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors. *Blueflex is our operating model which optimizes culture, productivity, & flexibility by maximizing the critical strengths of in-person work with the benefits of added flexibility. Blueflex allows for mix of in-office and remote work, enables flexibility to meet individual and business needs and makes effective use of our facilities and resources. It is a culture enhancer. #LI-Hybrid #LI-NJ1

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. About the Internship Program Caribou's Summer Internship Program is designed to give students and recent graduates hands-on experience in biotech, technical operations, and business functions. Interns will work closely with mentors and teams on meaningful projects while gaining industry insights and professional development opportunities. The program includes networking events and an end-of-program showcase where interns present their work to Caribou leadership and peers. What You'll Do As a Preclinical Pharmacology Intern on the In Vivo Pharmacology team, you'll gain hands-on experience in in vivo model development while contributing to real projects that matter. You'll be part of a supportive team that will challenge you to grow and help you build the skills you need for your future career. Your work may include: * Assisting with determining cytokine levels and immune cell populations in humanized mice * Supporting Pharmacology with data analysis, study design, literature searches, implementing tumor models, and research tasks * Attending team meetings and sharing ideas * Preparing and reviewing presentations, data packages, and study reports * Collaborating with your mentor to troubleshoot challenges and find solutions * Participating in intern events like networking sessions, team-building activities, and the final project showcase What You'll Gain * Hands-on experience with rodent handling, human tumor xenograft models, tissue collection, animal model development * Exposure to regulatory guidelines and quality standards in biotech * A mentor who will guide your learning and professional growth * Opportunities to connect with leaders and teams across the company * A chance to make a real impact and contribute to Caribou's mission * Experience presenting your project in our intern showcase What We're Looking For * Currently pursuing a degree in biology, bioengineering, or a related area * Some experience with mammalian cell culture, flow cytometry, ELISA, handling laboratory rodents is a plus but not required * Interest in oncology, cell therapy, and in vivo modeling * Strong organizational, problem-solving, and communication skills * Ability to work both independently and as part of a team * For lab-based internships, must be at least 18 years old for safety reasons Eligibility * Must be legally authorized to work in the U.S. (foreign students must have OPT approval from their school) * Must be able to work onsite in Berkeley, CA, for 5 days per week, based on manager preference * Must sign a university release form (provided by Caribou) acknowledging intellectual property terms and internship conditions * If submitting a poster to an external university program (e.g., QB3), must complete Caribou's publication clearance form. The intern's manager is responsible for ensuring timely submission Nice to Have Qualifications * Interest or experience in developing animal models, cell-based therapeutics, in vivo gene editing * Familiarity with GraphPad Prism, FlowJo, and Excel software Compensation & Perks * Range for this Paid full time internship is $26/hour with a 2-3 month duration * Professional development, networking, and mentorship opportunities * A chance to work alongside some of the brightest minds in biotech * Interns are responsible for their own housing and transportation Equal Opportunity Employer Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, hair texture of type, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. We do not accept unsolicited resumes or candidate submissions from staffing agencies. Any resume submitted without a valid agreement in place will be considered unsolicited, and Caribou Biosciences will not be obligated to pay any referral or placement fee.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. We are seeking an IT/Senior IT Support Specialist to provide front-line assistance for our compute platforms, audio video conference rooms, asset management, software/hardware break-fixes, assist with infrastructure securities and policies, office peripherals and mobile devices. This position affords numerous opportunities to learn and grow inside a dynamic startup environment. The successful candidate will have a demonstrated ability to wear many hats - to be flexible and resourceful in addressing new challenges as they arise. Responsibilities: * As the "front line" of our IT team, you'll be the first person employees interact with about their IT issues and requests * Effectively triage, document, communicate, and escalate any IT incidents and requests leveraging our IT Service Management (ITSM) solution * Follow up with other IT staff as needed to ensure incidents are resolved, requests are fulfilled, and the customer communication process is complete * Provide support across the company. Analyze, diagnose, troubleshoot and resolve IT issues including but not limited to hardware repairs or replacement parts, debugging, software updates, etc. * Fulfill the IT onboarding and offboarding processes, including provisioning new employee laptops, account creation, IT orientation, coordination with HR, and other related duties * Create a positive customer support experience and build strong relationships by communicating progress on user support issues, resolving or escalating issues in a timely manner and handling customers in a consummately professional manner * Participate in on-call rotation, monitoring for email-based alerts, urgent requests, and other potential issues on weeknights and weekends * Support onsite and remote AV technology including but not limited to Zoom, Zoom Rooms, AirPlay, and iPads. Coordinate service calls with AV vendor as needed for escalations * Seek opportunities to improve IT processes, including but not limited to finding workflows that can be automated, documentation gaps, proficient follow-ups, time management and process inefficiencies. * Engage in special projects and other tasks as assigned by IT Leadership Qualifications: * Bachelor's Degree in IT/IS, Computer Science, or related field or equivalent experience and certification * 3+ years of experience in an enterprise helpdesk environment supporting both onsite and remote staff * 3+ years of experience supporting employee workstations on Windows 10, Windows 11, MacOS and mobile operating systems * Ability to troubleshoot issues with hardware and software including but not limited to MacOS, Windows OS, Microsoft Office, Printers, WIFI, VOIP, and MFA * Understanding of the entire IT Asset Lifecycle and proven experience deploying workstations, repairing workstations, submitting warranty claims, and upgrading workstations * 3+ years of experience supporting conferencing platforms such as Zoom, Teams and A/V conference rooms * Understanding of TCP/IP concepts * Professional, courteous and committed to providing amazing customer support * Excellent follow-up and organizational skills * Exceptional customer service, teamwork and communication skills * Excellent time management skills * Strong critical/analytical thinking, problem-solving and time management skills * High energy level, adaptive and a strong team player with a good work ethic * Ability to write clear, concise and user-friendly documentation * Ability when given tasks and projects to see them through to completion * Experience with ITIL, ITSM platforms * Ability to lift 50+ lbs * Occasionally, I need to work nights and weekends and be available to rotate on-call and in-person emergency support Nice-to-haves: * Experience with Zendesk is a plus * Experience with Okta is a plus * Experience with Intune/Entra/Active Directory is a plus * Microsoft and or Apple Certifications Caribou compensation and benefits include: * Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees * Salary Range: $110,000 to $125,000 - This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance. * Generous paid vacation time, in addition to company-observed holidays and floating holidays * Excellent medical, dental, and vision insurance * 401(k) retirement savings plan, which includes matching employer contributions * Employee stock purchase plan (ESPP) * Tuition reimbursement program The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, hair texture of type, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee. #LI - ONSITE

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior Project Admin Coordinator, oversees activities for senior leadership, including managing complex calendars, organizing meetings, and arranging travel logistics. They serve as a primary point of contact for various meetings, events, presentations and projects. Key Accountabilities/Core Job Responsibilities: Confidentially coordinate activities for assigned members of Denali Senior Leadership. This includes management of a complex calendar(s) and organizing BOD, advisory and investor meetings when required. Coordinate travel arrangements and associated logistics with shifting priorities and deadlines. Plan and organize meetings, prepare agendas, provide research and background information, create presentations and coordinate all logistics. Represent Senior Leadership to external constituencies by serving as the primary point of contact and assessing requests and questions. Make autonomous, accurate and swift judgments, including forwarding questions and requests to other senior staff. Prepare Senior Leadership for internal/external meetings by researching organizations and individuals, bringing together resources to aid in preparation, and compiling relevant materials. Anticipate the business needs for Denali Senior Leadership and senior team by proactively formulating and evaluating solutions and/or recommendations to facilitate meeting deadlines and achieving goals. Compose correspondence. Develop, review, and edit presentations and documentation. Independently research and analyze associated issues and/or compile materials needed for presentation and/or decision-making purposes. Manage multiple projects simultaneously. Anticipate and track initial dates, events, and associated action items; follow up with appropriate parties on behalf of supervisor to ensure deadlines are met. Support event planning and execution. Maintain accurate and timely recording of work time by clocking in and out using designated timekeeping systems. Adherence to company timekeeping policies, including rules regarding overtime, meal breaks, and reporting procedures for any discrepancies. Qualifications/Skills: High school diploma or equivalent and 5+ years of administrative support experience required Proven track record of supporting senior-level leadership Demonstrated ability to handle sensitive issues and maintain the utmost confidentiality Demonstrated ability to perform duties with a high level of professionalism, flexibility, discretion, judgment, diplomacy, and tact Exemplary internal and external interpersonal and customer service skills Ability to multitask, adapt to changing priorities and deadlines Advanced computer skills and demonstrated experience with office software and G-Suite Excellent verbal and written communication skills, including editing and proofreading Growth mindset with interest and curiosity to learn new things Ability to adapt to changes in a rapidly scaling organization Excellent planning and organizational skills Ability to take initiative and ownership of projects Preferred Qualifications Bachelor's degree Biotech industry experience Previous experience working for a global organization Hourly Range: $45.67 to $55.05 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position is responsible for developing efficient, robust and scalable purification processes to support our large molecule pipeline. Key Accountabilities/Core Job Responsibilities: Design and execute lab-scale chromatography and filtration studies to inform and support large scale process decisions Maintain existing workflows to provide purification support for cell line and cell culture development activities Develop purification processes to support early and late-stage clinical production Execute methods for in-process testing using ELISA, HPLC, UV and SDS-PAGE based analytics Transfer purification processes to clinical manufacturing sites and support ongoing manufacturing campaigns as needed Author process descriptions, development reports, tech transfer documents and relevant IND sections Work closely with discovery groups and project teams to transfer process/molecule knowledge into development Qualifications/Skills: PhD in Biology, Biochemistry, Chemical Engineering, or related scientific discipline with 0-5 years of purification process development experience in academia/industry or BS or MS with 5+ years of industry experience Experience developing protein purification processes to support early or late-stage clinical production Experience with late-stage process characterization and validation is a plus Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOs Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies is desired Broad experience in protein characterization, multivariate experimentation and analytical techniques Expertise in AKTA protein purification, tangential and normal flow filter sizing Excellent critical thinking, scientific problem-solving and communication skills Salary Range: $125,000.00 to $157,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This role involves leading a dedicated team within the Development Sciences organization, collaborating with Discovery Sciences, Translational Medicine, and Regulatory teams, and providing scientific and strategic input to advance promising drug candidates to clinical trials. The ideal candidate will possess a strong background in pharmacokinetics, drug disposition, biodistribution, and translational pharmacology, with a proven track record in advancing molecules through CTA/IND milestones to first-in-human clinical trials. Key Accountabilities/Core Job Responsibilities: Deliver on key Project Team objectives and advance portfolio of blood-brain-barrier penetrant TV biotherapeutics by providing scientific contributions in areas of pharmacokinetics, drug disposition and biodistribution, and translational pharmacology/pharmacodynamics Lead and manage a group within the Development Sciences organization, providing strategic project-focused vision and oversight to advance drug candidates from Discovery through CTA/IND-enabling studies into Early Clinical Development. Participate on Project Teams as a subject matter expert contributing to the optimization and selection of lead clinical candidates, and support Group members serving in this role Design nonclinical PK/PD studies to answer translational questions in support of project deliverables and first-in-human dose predictions; oversee TK analysis for non-GLP and GLP toxicology studies. Lead Project Teams or Pharmacology Technical Teams in the CTA/IND-enabling stage. Serve on the Development Sciences Leadership Team; set Function and Organizational goals. Establish and maintain productive relationships with key partners within the organization, including Discovery Sciences, Bioanalytical Sciences, Safety Assessment, Clinical Pharmacology, Translational Medicine, and Regulatory to advance projects to key decisions and achieve development milestones. Analyze, interpret, summarize and communicate data to internal project teams, senior management, global health authorities, and strategic partners. Author and review nonclinical and clinical sections of regulatory filings. Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: A highly motivated individual with a PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology/Toxicology, Engineering, or related field and 10+ years of relevant work experience to include any postdoctoral work; must also have demonstrated experience as a people manager / mentor / coach Established expertise in biotherapeutic drug disposition and pharmacokinetics, with experience identifying clinical candidates and successfully advancing molecules through CTA/IND milestones to FIH clinical trials. Proven track record evaluating drug properties that may impact PK, investigating PK/PD relationships, and identifying relevant bioanalytical methods (ligand binding assays, mass spectrometry, or other methodologies) to assess biotherapeutic drug disposition. Well developed leadership skills in managing groups and developing scientific talent. Experience serving and/or leading cross-functional Project Teams, with success contributing to data driven decision-making, outlining strategies to enable drug development, and working collaboratively. Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results. Excellent oral and written communication and presentation skills. Salary Range: $213,000.00 to $255,667.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely About the Internship Program Caribou's Summer Internship Program is designed to give students and recent graduates hands-on experience in biotech, technical operations, and business functions. Interns will work closely with mentors and teams on meaningful projects while gaining industry insights and professional development opportunities. The program includes networking events and an end-of-program showcase where interns present their work to Caribou leadership and peers. What You'll Do As a Process Development Intern on the Process Development/ Technical Operations team, you'll gain hands-on experience in optimizing Caribou's platform manufacturing process for gene-edited cell therapies and contribute to projects with immediate impact. You'll be part of a supportive team that will challenge you to grow and help you build the skills you need for your future career. Working closely with our PD team, you will have the opportunity to interact with our engineers to provide support and gain hands-on experience. You will leverage quality by design principles to solve real-world issues in the cell therapy space within the context of Caribou's manufacturing platform. In this role, you will leverage your existing skillset and learn new skills to identify process gaps and leverage industry standard techniques to engineer solutions. Your work may include: * Learn cGMP-compatible CAR-T cell separation, cell enrichment, cell expansion, gene editing, final formulation, and related processes for scale-up techniques * Learn and use engineering principles to leverage bench and pilot scale models for cell therapy manufacturing process performance characterization * Design and execute characterization studies, evaluate product impact of scale-up and/or raw material changes * Learn scale-up of operations compatible with applicable quality assurance guidelines * Generate development reports and prepare SOPs and batch records * Participate in cross-functional teams and working in a highly matrixed team environment * Assisting with designing and executing characterization studies in relation to T cell isolation, activation, expansion, and raw material changes. * Optimization of critical process parameters using QbD principles utilizing DoE approaches. * Supporting Process Development/ Technical Operations with cell-based assays, data analysis and compilation. * Attending team meetings and sharing ideas * Preparing and reviewing protocols and presentations * Collaborating with your mentor to troubleshoot challenges and find solutions * Participating in intern events like networking sessions, team-building activities, and the final project showcase What You'll Gain * Hands-on experience with cGMP-compatible CAR-T cell isolation, cell enrichment, cell expansion, gene editing, final formulation, and related processes for scale up. * Exposure to regulatory guidelines and quality standards in biotech * A mentor who will guide your learning and professional growth * Opportunities to connect with leaders and teams across the company * A chance to make a real impact and contribute to Caribou's mission * Experience presenting your project in our intern showcase What We're Looking For * Currently pursuing a degree in Biology, Bioengineering, or a related area * Some experience with cell culture is a plus but not required * Interest in biotechnology, immunology, cell therapy, process development and optimization. * Strong organizational, problem-solving, and communication skills * Ability to work both independently and as part of a team * For lab-based internships, must be at least 18 years old for safety reasons Eligibility * Must be legally authorized to work in the U.S. (foreign students must have OPT approval from their school) * Must be able to work onsite in Berkeley, CA, for 5 days per week, based on manager preference * Must sign a university release form (provided by Caribou) acknowledging intellectual property terms and internship conditions * If submitting a poster to an external university program (e.g., QB3), you must complete Caribou's publication clearance form. The intern's manager is responsible for ensuring timely submission Nice to Have Qualifications * Interest or experience in immuno-oncology, the pharmaceutical or biotechnology industry. * Familiarity with FlowJo, JMP, GxP, and immune cell engineering. Compensation & Perks * Range for this Paid full time internship is $26/hour with a 2-3 month duration * Professional development, networking, and mentorship opportunities * A chance to work alongside some of the brightest minds in biotech * Interns are responsible for their own housing and transportation Equal Opportunity Employer Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, hair texture of type, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. We do not accept unsolicited resumes or candidate submissions from staffing agencies. Any resume submitted without a valid agreement in place will be considered unsolicited, and Caribou Biosciences will not be obligated to pay any referral or placement fee.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Key Accountabilities/Core Job Responsibilities: Strategic Leadership and Vision Development and implementation of comprehensive IT strategies that align with Denali's mission and organizational goals. This includes understanding Denali's broader business objectives, synthesizing, and translating technology strategies that enable our portfolio and commercial goals. You will collaborate with executive leadership to influence company-wide technology decisions and ensure that IT investments are strategically focused on driving growth and efficiency. Commercial IT Focus You will partner with Denali's commercial teams to support technology strategies and execution in the planning, marketing and sales of our drug products. You will Implement technology solutions that enhance customer engagement, improve market positioning, improve commercial insights and stay informed about industry trends and emerging technologies relevant to commercial operations. Your previous experience and insights will contribute to strengthening our competitive position in the market. IT Portfolio Governance Establish and oversee IT portfolio management processes to ensure alignment of IT projects and initiatives with business objectives and the business planning cycle. You will evaluate and prioritize IT investments, identify resource allocation needs across projects and programs, and implement governance strategies to manage project risks, interdependencies, and value realization. Regularly monitor and report on the performance of the IT project portfolio to leadership providing transparency and facilitating informed decision-making. Authentic Technical Leadership You will exemplify authentic technical leadership by leveraging your extensive technical expertise to provide insightful and accurate guidance on IT strategies and initiative to make informed decisions rooted in evidence, industry best practices, and proven methodologies by sharing knowledge and insights openly and honestly, ensuring all communications are grounded in factual information, you will foster transparency and trust within the team and across the organization. Cultural Leadership and Community Engagement Actively participate in Denali activities and functions, building culture and relationships in a meaningful and professional manner with your colleagues. You will promote a positive environment by demonstrating respect, integrity, inclusiveness, and dedication in all endeavors, fostering a collaborative and supportive environment. Effective Communication and Collaboration Deliver clear and impactful communications to the company, leadership, and the executive team articulating IT's vision and progress in a straightforward and understandable manner. You will build strong relationships across all levels of the organization, enhancing collaboration and cultural cohesion. Your ability to convey complex technical concepts clearly and succinctly will ensure that messages are easily understood by technical and non-technical audiences alike. Governance, Compliance, and Risk Management Establish and enforce IT policies, standards, and procedures to ensure compliance with regulatory requirements and industry best practices. Drive IT risk management activities, including healthcare compliance, data privacy, cybersecurity, and disaster recovery planning, ensuring that all initiatives are rooted in solid data and proven methodologies. Operational Excellence and Results Orientation Oversee key IT functions-including infrastructure, applications, and support services-to ensure operational excellence. You will manage large-scale IT projects, ensuring they are delivered on time, within scope, and within budget, demonstrating strong organizational and prioritization skills. By implementing processes and methodologies that enhance efficiency and effectiveness, you will drive initiatives forward independently, requiring minimal supervision. Financial Management and Accountability Develop and manage budgets for assigned IT functions and projects, ensuring cost-effective utilization of resources. You will analyze and report on IT performance metrics, ROI, and value delivery to leadership, demonstrating your ability to evaluate and justify significant IT investments. Leadership and Team Development Lead and mentor IT managers and teams, including leading direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Through this, you will a instill a culture of innovation, accountability, and continuous improvement and will inspire high performance by motivating teams to achieve exceptional results and encouraging them to go beyond the status quo. By identifying and developing future leaders within the IT department, you will contribute to our talent management strategies and promote professional growth among team members. Qualifications/Skills: Bachelor's degree in Computer Science, Information Systems, Business Administration, or a related field; MBA preferred 15+ years of progressive experience in information technology with 10+ years in senior leadership roles within large, complex organizations. At least 5 years in the pharmaceutical or healthcare industry, focusing on commercial IT operations Demonstrated success in developing and implementing IT strategies that drive business growth, efficiency, and innovation. Substantial experience in a technical discipline (e.g. engineering, coding, system development) with the ability to contribute directly to technical work alongside development teams. Proficient in cloud computing, data analytics, and enterprise systems. Experience leading enterprise architecture and system design initiatives. Proficient in core IT frameworks and standards, including ITIL, COBIT, TOGAF, ISO/IEC 27001, NIST Cybersecurity Framework, and CIS Controls Experience in IT financial planning and management, including budgeting and cost optimization. Strong ability to evaluate and justify significant IT investments Professional certifications such as PMP (Project Management Professional), ITIL (Information Technology Infrastructure Library), or CISSP (Certified Information Systems Security Professional) are highly desirable Salary Range: $257,373.00 to $294,500.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking a highly skilled Director of Safety Science to lead clinical and post-marketing safety surveillance, ensuring patient safety and regulatory compliance. This role directs safety signal and risk management activities, oversees adverse event reporting, and provides safety input for clinical and regulatory documents. Responsibilities include preparing global risk management plans, safety regulatory submissions (e.g., DSURs, PADERs), and supporting regulatory interactions, audits, and inspections. The position represents Drug Safety in internal and external meetings, tracks safety-related decisions, and maintains standard operating procedures (SOPs) to uphold best practices in pharmacovigilance. Key Accountabilities/Core Job Responsibilities: Responsible for the strategy and implementation of the program-specific clinical and post-marketing safety surveillance to ensure patient safety and regulatory compliance. Leads Safety Management Team(s) and directs all safety signal and risk management activities for assigned products. Contributes to review of adverse event reports to ensure the accuracy, integrity and completeness of information. Provide safety input to protocols, statistical analysis plans, clinical study reports, investigator's brochure, reference safety information, informed consent documents, and other clinical regulatory documents; prepare/review safety sections of new drug applications and other regulatory filings. Ensures local and global risk management plan preparation and execution throughout a product's lifecycle. Responsible for the completion of safety regulatory submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide. Tracks implementation of SMT and DSC decisions. Support responses to questions from regulatory authorities, regulatory agency audits and inspections, corrective action plans, and PV vendor oversight in collaboration with Safety Operations. Represents Drug Safety at internal (e.g. governance and leadership teams) and external meetings (e.g. regulatory authority), attending cross-functional or project-specific team meetings to provide safety expertise, as needed. Drafts and maintains standard work practice documents including standard operating procedures (SOPs), work instructions, forms and templates. Performs other tasks and assignments as needed. Qualifications/Skills: Advanced degree in health and related fields required. At or near 10 years of relevant work experience to include 7+ years in drug safety and pharmacovigilance and a track record of successful deliveries of core safety/PV activities in cross-functional safety teams. Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines. Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics. Willingness to teach and to learn. Salary Range: $213,000.00 to $265,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position is required to be based in San Francisco, CA. Key Accountabilities/Core Job Responsibilities * Legal Compliance: Advise on employment laws applicable to Denali's California, Utah, and Switzerland offices and remote employees, including wage and hour regulations, anti-discrimination laws, and leave policies. * Policy Development: Draft, review, and update employee handbooks, workplace policies, and SOPs to ensure compliance and alignment with Denali culture. * Employee Relations: Partner with HR to provide guidance on complex employee relations issues, investigations, and performance management. * Litigation and Risk Management: Manage and oversee the resolution of employment-related disputes and coordinate responses to agencies. * Hiring and Onboarding: Support the development of compliant hiring practices, offer letters, and onboarding materials. * Training: Develop and deliver training programs for managers and employees on employment law topics, including performance feedback, leave policies, and workplace conduct. * Immigration Oversight: Oversee and support immigration matters, manage relationships with immigration counsel, and ensure timely and efficient outcomes. * Cross-Functional Support: Collaborate with teams on employment-related aspects of business strategies, including international expansion and benefits. Support the establishment of a strong, integrated culture across sites. Skills/Qualifications: * J.D. degree from an accredited law school. * Active California bar membership in good standing. * 7+ years of relevant work experience. * Expertise in U.S. federal, state, and local employment laws and regulations required; familiarity with Swiss employment law preferred. * Proven experience advising on employee relations, policy development, and compliance. * Experience in the biotech, life sciences, or technology sectors preferred. * Strong project management skills and ability to prioritize in a fast-paced environment. * Exceptional verbal and written communication skills, the ability to communicate with tact and diplomacy, and a deep, abiding sense of compassion and integrity. * Growth mindset, with a willingness to learn new things, expand outside boundaries, and broaden areas of expertise. No task is too big or too small. * Ability to thrive efficiently in a fast-paced environment, managing a heavy workload at times and adapting quickly to change. * Excellent judgment, complemented by an awareness of when to seek guidance and collaboration. * Willingness to courageously and clearly identify risks and seek solutions. * A proven record of building trust and credibility through consistent and reliable partnerships with business functions. Salary Range: $225,000.00 to $272,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.