Denali Therapeutics Jobs In South San Francisco, CA

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 will provide supporting quality oversight of Denali's clinical and commercial manufacturing and laboratory networks. This role will also contribute to developing processes and procedures for Quality Assurance. Key Accountabilities/Core Job Responsibilities: * Supports commercial and clinical GMP quality operations, internally and externally, including quality documentation reviews and approvals, from Manufacturing and Quality Control, such as batch records, change controls and disposition of Denali products * Supports CMC technical operations including review, approval, and release of commercial packaging and labeling activities and commercial finished goods. * Supports investigation and closing of OOS, OOT, and/or deviations * Supports product quality aspects of the supply chain - commercial storage and distribution at respective 3PLs networks * Writes and implements changes to controlled documents (SOPs, Work Instructions, Specifications, etc.) as needed * Supports improvements in quality processes and systems and tracking/reporting of departmental metrics * Supports quality review of IND/IMPD/BLA Qualifications/Skills: * BS in a related scientific discipline * 5+ years of GMP experience in the Pharmaceutical industry * Experience with internal and external manufacturing (CMOs), CMC development with focus on large molecules * Experience of GMP Quality Compliance. * Current and strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines. * Able to travel domestically and internationally. 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. 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.

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.

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. 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. 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.

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 antitumor activity. 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 platforms as readily available treatments for patients with hematologic malignancies autoimmune disease. 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 a Bioinformatics Intern to support development of our cutting-edge cell therapies. This role offers hands-on experience working in a team environment to design and improve bioinformatics tools that guide our research efforts and improve outcomes for patients. The on-site position reports to a Principal Bioinformatics Scientist. Depending upon the applicant's qualifications, projects include: * Implement AI/ML models to predict protein interactions relevant to cell therapy. * Optimize CRISPR design using ML to enhance editing efficiency and specificity. * Design and benchmark bioinformatics algorithms for genomic data analysis. * Analyze single-cell/bulk RNA-seq using short and long-read sequencing to uncover novel insights * Build visualization platforms for R&D and translational applications using internal and public databases * Work with cross-functional teams, including scientists, bioinformaticians, and information technology, to translate computational models into actionable insights. * Contribute to research reports, presentations, and publications. Preferred Qualifications * Currently pursuing (or recently completed) a Bachelors, Master's or Ph.D. in Biology, Bioinformatics, Computational Biology, Machine Learning/AI, or a related field. * Experience with Python or R * Foundation in statistics and biological data analysis. * Knowledge of CRISPR editing technologies * Previous research experience in cell therapy, immunology, or synthetic biology. What You'll Gain * Hands-on experience at the intersection of bioinformatics, AI/ML, and cell therapy. * Mentorship from leading experts in computational biology and genomic engineering. * Exposure to real-world therapeutic development in a cutting-edge biotech environment. * The opportunity to contribute to high-impact publications and patents. 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 or 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. We are seeking to recruit an experienced Manager, Corporate Finance and Accounting to enhance the Company's finance function and become a key part of the team as we grow to support the business. This role will be responsible for overseeing and managing the operational accounts payable function and various other general ledger functions, as well as being a key contributor in the financial close process. This colleague will play a key role in establishing and maintaining a strong internal controls over the Company's accounts payable and cash processes. This is a hands-on working position that will also be responsible for assisting in the day-to-day management of the outsourced accounts payable team to ensure that invoices and payments are properly and timely processed. Key Accountabilities/Core Job Responsibilities: Responsible for day-to-day management of the outsourced accounts payable function Oversee preparation of weekly payment runs in accordance with established SOX processes and the recording in the general ledger all cash outflow transactions and reconcile bank accounts Manage complex and escalated vendor inquiries and requests while overseeing outsourced accounts payable team's responses to routine vendor inquiries Manage, in accordance with SOX and documented policies, response for any unprocessed or failed payments, vendor refunds or credits, and direct debit payments Support or manage other general ledger functions including R&D areas, balance sheet reconciliations, preparing and reviewing journal entries, and analyses as part of the monthly close process Support all accounts payable related annual processes, including annual audits/ quarterly reviews with external auditors, 1099's and other, as needed Assist with user acceptance testing of system and software implementations as needed Assist with the establishment and maintenance of internal controls and SOX 404 compliance Proactively seek ways to improve processes to help reduce time to close, improve accuracy of the underlying accounting records and improve operational efficiency Be able to manage and execute on special projects and support the corporate tax and treasury functions as needed Qualifications/Skills: Bachelor's degree or higher in accounting, finance or equivalent, and 5+ years of professional accounting experience, preferably in the biotech or pharmaceutical industry (without a degree, 8+ years relevant pharmaceutical / biotechnology experience is required) Must be able to demonstrate a thorough understanding of the Procure to Pay process Must be able to demonstrate a high attention to detail with an ability to independently prioritize and organize work assignments. Must possess excellent computer and analytical skills with proficiency in Excel and Word. Good communication skills both oral and written are required. Salary Range: $133,000.00 to $169,000.00 . 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: Lead purification/downstream process characterization, tech transfer, and late-stage activities Author protocols, coordinate study execution, review analytical results, generate/review reports, and author IND/BLA sections Coordinate internal team to generate late-stage process characterization and/or validation data packages Support selection/coordination of CDMOs as needed to generate high-quality late-stage data packages Transfer purification processes to CMOs and support ongoing manufacturing activities as needed Support other late-stage projects and apply lessons learned to current projects. 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 Execute methods for in-process testing using ELISA, HPLC, UV and SDS-Page based analytics Qualifications/Skills: BS in Biology, Biochemistry, Chemical Engineering or related scientific discipline plus a minimum of 10+ years of purification development experience in the biotech/biopharma industry. OR MS in Biology, Biochemistry, Chemical Engineering or related scientific discipline plus a minimum of 8+ years of purification development experience in the biotech/biopharma industry. OR PhD in Biology, Biochemistry, Chemical Engineering or related scientific discipline plus a minimum of 3+ years of purification development experience in the biotech/biopharma industry. Experience with purification process characterization and validation is required. Experience reviewing batch records and familiarity with Process Performance Qualification (PPQ) campaigns Familiarity with BLA authoring is preferred. Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOs Broad experience in process characterization, design of experiments and analytics Experience developing protein purification processes to support early or late-stage clinical production Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies, is desired Expertise in AKTA protein purification systems and antibody characterization methods including: HPLC, LC/MS, SDS‐PAGE, DLS and other biophysical techniques Excellent critical thinking, scientific problem-solving and communication 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.

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 in the Process Development, you'll gain hands-on experience in CAR-T process 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: * Learning cGMP-compatible CAR-T cell separation, cell enrichment, cell expansion, gene editing, final formulation, and related processes for scale-up * Using engineering principles to leverage bench and pilot scale models for cell therapy manufacturing process performance characterization * Designing and executing characterization studies, evaluating product impact of scale-up and/or raw material changes * Attending team meetings and sharing ideas * Preparing and reviewing datasets 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 wet-lab cellular engineering and manufacturing techniques, data capture and analysis, flow cytometery * 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 bioengineering, biology, chemical engineering, biochemistry or a related area * Some experience with aseptic technique and flow cytometry is a plus but not required * Interest in cell therapy, genome editing, process development * 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 * 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 cell therapy, genome editing, process development * Familiarity with Microsoft Office suite, aseptic technique, data analysis software like JMP 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 or 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. The company is seeking an experienced and highly motivated Development Sciences Operations Manager responsible for oversight of technical and operational aspects of Development Sciences workflows, including those conducted at external CRO laboratories in support of Toxicology, Pathology, Biomarker, Bioanalytical, and DMPK/Clinical Pharmacology functions. This individual will work in close collaboration with colleagues in Discovery Research and Development Sciences and will be responsible for working with members of cross-functional teams to liaise with Contract Research Organizations (CROs), monitor studies, manage vendor relationships and contracts, and potentially contribute to the design, execution, and reporting of nonclinical studies for Denali Therapeutics products. Key Accountabilities/Core Job Responsibilities: * Serve as Safety Assessment (Toxicology/Pathology), DMPK, Clinical Pharmacology, Biomarker, and Bioanalytical function interface between Denali and external CRO collaborators, developing productive relationships to achieve optimal efficiency in external workflows in GLP, GCP and GCLP areas. * Manage identification (RFI), partnering with Legal and Contracts group in managing the operational aspects of pre-clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets. * Manage study operational logistics, including establishing timelines for deliverables, facilitate test material logistics, and support the trafficking of samples, data, and documents * Provide support in implementing, managing, and monitoring outsourced nonclinical Toxicology studies (non-GLP and GLP) to support all phases of drug development * Remote and onsite oversight of nonclinical studies to ensure studies are conducted to the highest standards * Responsible for working with DMPK scientists to identify CRO laboratories capable of conduct of in vitro and in vivo experiments supporting candidate identification and IND-enabling efforts. * Engage CROs and internal scientists to outline protocols/SOWs. * Receive and review study results and summary reports, ensuring data and reports are integrated into internal databases; help design tools to aid in data upload, migration, and visualization. * Ensure compliance with study protocols, IACUC regulations, and SOPs. Qualifications/Skills: * BS/MS in Toxicology, Pharmacology, Biological Sciences or related discipline with 3+ years of biopharmaceutical industry experience. * Experience working with nonclinical CROs, developing protocols, and an understanding of technical and organizational aspects of study conduct, including knowledge of current animal welfare philosophies and 3Rs. * Ability to perform data entry into data warehouses (e.g., Dotmatics/Benchling) and manage data visualization software (Tableau, SEND explorer). * Outstanding organization and planning skills, and the ability to assess risks and manage external workflows to meet project team deliverables. * Excellent analytical, critical thinking, and soft skills to build collaborative relationships enabling effective professional interactions with vendors and stakeholders. * Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit. Salary Range: $133,000.00 to $169,000.00 . 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 Opportunity We are currently seeking a highly motivated, independent scientist to support in vivo work in our Preclinical Translational Sciences group. The primary function of this position is to identify and develop relevant animal models for biomarker discovery, assessment of target and biological pathway modulation, and establishing PK/PD relationship with Denali's therapeutic candidates. This role will have a specific focus on the development and characterization of Parkinson's disease rodent models to identify potential translatable biomarkers that can be used to support our therapeutic teams. This role will need to work cross functionally as well as with colleagues within Discovery and Development Sciences to design, conduct, and provide strategic guidance to project teams. The Scientist role will be critical in generating data to support multiple research programs at Denali Therapeutics, ultimately contributing to the discovery and development of novel therapeutics for the treatment of neurodegenerative diseases. Responsibilities (included but not limited to the following) Develop and conduct hands-on experiments to characterize Parkinson's disease rodent models utilizing techniques such as immunohistochemistry, microscopy, immunoassays, etc. and exploring novel endpoints relevant to Parkinson's disease Lead efforts and collaborate with cross functions (i.e. Discovery, Development Sciences, Translational Medicines) to identify robust and translatable target, pathway, and disease biomarkers in relevant animal models Design, implement, and assist in acute and chronic animal studies to evaluate biological effects of therapeutic candidates Serve on large molecule project teams throughout lead/candidate identification, IND-enabling, and Early Clinical Development phases to enable project decision making Design and communicate experimental study designs and analyze, interpret, and present data and experimental conclusions to cross-functional teams Support functional related goals within the Preclinical Translational Sciences team as needed Requirements PhD. in a relevant field (preferably neurobiology). Additional industry or postdoctoral experience is desirable but not required. Proficiency in designing and implementing in vivo studies with experience in rodent handling, dosing, and tissue / fluid collection; stereotaxic experience preferred. Preferred hands-on experience with Parkinson's disease rodent models. Experience in biochemical, molecular and cellular techniques (i.e. plate based immunoassays, FACs, immunohistochemistry). Ability to think strategically and work effectively in a fast-paced environment with excellent time management skills, strong scientific rigor, and attention to detail. Excellent interpersonal and communication skills as well as the ability to work effectively as part of a cross functional team. Salary Range: $123,000.00 to $158,000.00 . 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: 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.

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: Provide clinical, scientific, and strategic leadership for translational and early clinical projects, including leading early clinical-stage project teams Responsible for the design, execution, analysis, interpretation, and presentation of clinical and translational studies Plan, organize, and direct the activities of clinical trials, including development of clinical protocols and amendments, investigator brochures, and clinical study reports Provide medical monitoring support, including evaluation of safety, pharmacology, and efficacy of ongoing and completed studies Establish and implement exploratory pharmacodynamic, diagnostic, and biomarker plans in conjunction with partners in Clinical Pharmacology and Translational Sciences Interact with external thought leaders, key disease community stakeholders, including advisory boards, to support clinical and translational development Establishes, leads, and manages relationships with key development partners as applicable. Represent team and organization strategy to decision/governance meetings. Participate in the development and execution of strategies for new product development and lifecycle growth, including regulatory and investigator interactions Prepare literature reviews, external presentations, and publications as appropriate Qualifications/Skills: MD or MD/PhD physician-scientist with strong understanding of translational disease biology and a track record of designing and executing innovative early-stage trials 2+ years clinical development experience in industry. Extensive experience in drug development or clinical trials in other settings (e.g. academia, government) may be considered. A strong track record in team leadership, development of clinical-regulatory strategies, and/or industry-academic collaborations Training in adult or pediatric neurology or research experience in neuroscience preferred but not required Interest and flexibility to work across multiple indications with high unmet need and ability to develop expertise in new disease areas quickly Excellent presentation skills and ability to communicate effectively with external partners and with preclinical, biomarker, regulatory, operations, biostatistical and computational collaborators Salary Range: $252,000.00 to $300,000.00 . 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.