CRISPR Therapeutics Jobs In Framingham, MA

- 22 Jobs
  • Manufacturing Associate

    Crispr Therapeutics AG 4.6company rating

    Crispr Therapeutics AG Job In Framingham, MA

    Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. Position Summary Reporting to the Manufacturing Manager, the Manufacturing Associate will perform manufacturing activities associated with immuno-oncology GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of allogenic gene edited cell therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing aseptic cell culture within a GMP environment. Responsibilities * Perform clinical / commercial product manufacturing for a cell and gene therapy according to cGMP standards and SOPs. * Perform aseptic cell culture, aseptic vial filling, visual inspection, cryopreservation, process media formulation, media component aliquoting and kitting. * Transfer raw material inside cleanroom suite using sanitizing reagents or equipment. * Participates in technology transfer from Process Development to the Manufacturing group. * Assists in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups. * Ensures all materials and equipment are identified and available in time for manufacturing operations. * Transfer raw material inside cleanroom suite using sanitizing reagents or equipment. * Executes standard work per manufacturing schedule * Participate in Quality investigations and resolutions. * Ensures cGMP compliance through consistent execution. * Other duties and projects as assigned to meet departmental requirements. Minimum Qualifications * Certificate, associate's or bachelor's degree in biological sciences or related fields * 3+ years of relevant Manufacturing experience or related fields (cell culture, support, media prep) * Available to work a flexible schedule as needed. * Ability to don cleanroom garments and work within a classified environment (Grade B and C) * Knowledge of GMP and industry standards * Fluency in Windows and Microsoft Office applications * Attentive to detail and accuracy * Ability to effectively communicate and collaborate with internal stakeholders is essential * Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion * Ability to lift 40 pounds * Ability to stand for 6 hours in a clean room environment * Self-driven, independently motivated, data driven and excellent problem-solving ability Preferred Qualifications * Prior experience in cell or gene therapy manufacturing Competencies * Collaborative - Openness, One Team * Undaunted - Fearless, Can-do attitude * Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. * Entrepreneurial Spirit - Proactive. Ownership mindset. Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************
    $36k-51k yearly est. 60d+ ago
  • Associate Director, Automation Engineering

    Crispr Therapeutics AG 4.6company rating

    Crispr Therapeutics AG Job In Framingham, MA

    Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. Position Summary The Associate Director of Automation Engineering will be responsible for operational support, expansion, and continuous improvement of the 33 New York Ave, Framingham, MA manufacturing facility computerized systems, primarily, Rockwell PlantPx for critical utility monitoring and Delta Controls Entelliweb for building management control and monitoring. This role will report to the Head of Engineering/Validation and work closely with IT Infrastructure and IT Compliance to ensure reliability and compliance with 21CFR part 11 requirements. Responsibilities * Directs internal and external resources to maintain and drive improvement of computerized systems including Rockwell PlantPx, Delta Controls Entelliweb, and process and analytical equipment. * Responsible for system administration of computerized process and analytical equipment and all required activities associated to maintain compliance. * Lead development and achievement of site long range digital technology plan. * Ensure that computerized systems are in good standing for Regulatory Agency Inspections. * Create, own, and maintain any identified gaps in policies and procedures. Minimum Qualifications * Bachelor's degree (engineering or other relevant discipline preferred) * 12+ years in the Pharma/Biopharmaceutical industry in Automation/Digital engineering function in support of a GMP-compliant manufacturing environment * 4+ years managing internal and/or external resources * Excellent interpersonal, verbal and written communication skills * Process-oriented with strong analytical skills for risk identification and management * Excellent organizational and time management skills; experienced in setting priorities and meeting deadlines in a fast-paced environment with changing priorities while maintaining attention to detail; project management experience desired * Experience with Rockwell PlantPx is strongly preferred * Experience with using KNEAT for validation Competencies * Collaborative - Openness, One Team * Undaunted - Fearless, Can-do attitude * Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. * Entrepreneurial Spirit - Proactive. Ownership mindset. Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************
    $112k-168k yearly est. 3d ago
  • Manager, Commercial Meetings & Events

    Ardelyx 4.1company rating

    Waltham, MA Job

    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The Commercial and Meeting Operations Manager plays a vital role on the Commercial team, ensuring efficient operations for commercial initiatives and internal meetings. This role requires an organized, proactive approach to managing the detailed timelines of events, cross-functional collaboration, and team meeting logistics. Reporting to the Senior Director, Commercial Operations, this position collaborates closely with internal and vendor partners to deliver exceptional event experiences. Responsibilities: Oversee planning, site selection, logistics, vendor management, and on-site management for Commercial meetings, including sales meetings and events such as the National Meeting Track and manage budgets for event logistics and associated expenses, coordinating approvals and expense documentation to ensure fiscal accountability Manage project timelines and maintain alignment across all Commercial functions, based on the strategic plan and tactical objectives by utilizing Smartsheet or similar project management tool Provide project status updates to stakeholders, providing insights on milestones, timelines, and any adjustments to keep everyone aligned Manage multiple events with careful attention to timelines, budgets, and logistical details with the ability to manage competing priorities while maintaining a positive and collaborative approach Work with internal stakeholders across departments and with external partners to achieve shared objectives, fostering positive relationships Anticipate needs and propose solutions processes to mitigate delays or issues Qualifications: Bachelor's degree with 5+ years of event planning and logistics or related experience in the pharmaceutical, scientific, or biotech sectors Event planning certification preferred Proficient in project management software (e.g., Smartsheet), with strong organizational, multitasking, and communication skills Detail-oriented, proactive, skilled in relationship management, with a customer-focused mindset Proficient in project management software (e.g., Smartsheet), Microsoft Excel, and skilled in organization, multitasking, and communication Dedicated to delivering high-quality experience for both internal colleagues and external stakeholders Work Environment: Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $106,000-$130,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $44k-60k yearly est. 3d ago
  • Manager, Pharmacovigilance Operations

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary: Reporting to the Director, Pharmacovigilance Operations, you will have a broad scope of responsibilities that includes participating in the oversight of the day-to-day operational ICSR activities of the vendor across multiple studies, tracking regulatory submissions to ensure compliance to regulatory timelines, and a highly visible role in representing PV operations in cross functional study teams and other key department initiatives. Your role: * Serve as the PV operations lead for the assigned studies and be responsible for managing and completing all PV deliverables for those studies * Partner with the Tango regulatory operations team and be the primary point of contact for tracking all submissions of expedited reports, ensuring high compliance with regulatory timelines * Be involved in analyzing safety data from an operations perspective to make sure that the PV processes are performed in a consistent and compliant manner across all Tango programs * Participate in the review of study plans, including protocols, safety management plans, CRF completion guidelines, data validation manuals, and take part in the necessary UAT testing for EDC modifications * Manage the review of PV documentation in the TMF, and report any findings to the TMF lead in Clinical Quality and Compliance * Assist with monitoring internal drug safety mailbox, and triage communications with the appropriate colleagues to ensure timely action * Participate in a routine assessment of vendor performance and apply your expertise/experience in making recommendations for improvement to any identified gaps * You will be an integral part of a high-functioning PV Operations team and support any other ad-hoc projects as needed What you bring: * At least 3 - 5 years' experience in PV Operations * Bachelor's degree in life sciences or nursing * Experience with safety databases (ARGUS, ARISg, and/or Veeva) required * Good knowledge of FDA and EMA regulations required * Oncology experience is a plus but not required * Familiarity with MedDRA coding desirable * Critical thinking, proactive and keen attention to detail * Be able to work well independently as well as a team player * Strong work ethic and interpersonal communication * Positive attitude and enthusiasm to adapt to changing timelines and deliverables We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $81k-128k yearly est. 8d ago
  • Director, Commercial Forecasting

    Ardelyx 4.1company rating

    Waltham, MA Job

    Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Director, Commercial Forecasting Job Summary The Director, Commercial Forecasting will be responsible for evolving capabilities in forecasting, including developing strategy related to forecasting methodologies, processes, and technologies that will enhance decision-making and planning across the organization. This role will be a key member of the Commercial Operations & Analytics team and will partner closely with cross-functional stakeholders (e.g., Marketing, Sales, Business Development, FP&A) to optimize estimation and articulation of the commercial opportunity for IBSRELA and XPHOZAH . This is a hands-on role that requires an entrepreneurial mindset and a willingness to execute all aspects of forecasting, from modeling to creating a narrative and driving the company to action. The position will be based out of the Ardelyx headquarters in Waltham, MA and may require some travel. This role will report to the Executive Director, Business Analytics. Responsibilities: Owning development and execution of US and global forecasts, including market, demand, distribution and revenue assumptions across multiple products and indications. Provide short-term forecasts for in-line product performance and long-range forecasts for strategic planning while incorporating market trends, competitive intelligence, and industry benchmarks Integrating secondary data analyses (script and dispense data, claims analysis) and primary market research insights to support forecast assumptions Ensure forecasts are updated regularly to reflect new data, market changes, and business assumptions, aligning with recurring business reviews & set budget planning & forecast cycles Maintaining an up-to-date view of key risks and opportunities in the short, mid and long-term based on tracking of actual product performance vs. forecast expectations. Drive multiple forecast iterations for scenario planning around these identified risks and opportunities Driving consolidation and delivery of the forecast narrative to executive leadership & commercial leadership teams Proposing methodology, process improvements, and technology solutions, then getting buy-in from cross-functional leaders and leading implementation of such solutions Working closely with vendor partners (Komodo, IQVIA, Symphony and others) to identify analogs and benchmarks to support forecast assumptions Partner cross-functionally across the Ardelyx organization to support all forecast needs from a commercial perspective. This includes but is not limited to: Supporting Market Access team with forecasting needs related to Patient Services (ArdelyxAssist) including developing models to assess the impact of patient service initiatives on product persistence and adherence Collaborate with the Corporate Development team to evaluate potential partnerships, licensing opportunities, and acquisitions by providing robust forecasts and market insights; conduct market assessments and financial modeling to support deal valuation and negotiation Partnering with Supply Chain for supply forecasts including commercial, PAP and sample volume projections Partnering with Finance and FP&A teams to assess market dynamic impacts on product revenue generation, including implication on gross to net discounting, and the overall financial profile of the company Minimum Qualifications Bachelor's degree required; MBA or other advanced degree preferred 10+ years of industry experience, with 5+ leadership experience in demand forecasting within a pharmaceutical/biotech company or healthcare consulting firm (will consider related experience) Expertise in MS Office (Excel/PowerPoint) & proficiency with BI platforms (Tableau, Power BI) Experience with secondary pharmaceutical data (e.g., Komodo claims data, audited script data (IQVIA or Symphony Health), and epidemiology references) Expertise in developing product forecasts, market assessments, and competitive intelligence analyses, especially in markets with nuanced reimbursement dynamics Proven track-record of working with senior leadership on forecast development and communication Skills Familiarity with pharmaceutical product revenue cascades, including gross to net calculations for pharmacy and medical benefit products; experience with government pricing calculations (Medicaid AMP, Medicare ASP/TDAPA, VA FSS/FCP etc…) preferred Experience with launches and commercialization of pharmaceutical products with related advanced analytical modeling Strong quantitative and analytical skills, with the ability to extract and quickly process key information, summarize needs of cross-functional teams, and provide targeted and appropriate insights and recommendations Extensive knowledge of pharmaceutical data (e.g., ex-factory, 867, TRx, specialty pharmacy, inventory, payer, promotional & marketing data including digital/omnichannel, longitudinal patient-level data) Experience working with life science consultants (examples include, but not limited to, Trinity, Komodo, Beghou, IQVIA) Strong blend of technical proficiency, business acumen, and experience informing business growth and opportunity Strong verbal and written communication skills Skilled at leading without authority in a cross-functional environment Collaborative and influential leadership style, with the ability to build strong partnerships across the organization Ability to work in a fast-paced environment with strong attention to detail and accuracy The anticipated annualized base pay range for this full-time position is $200,340-244,860. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $200.3k-244.9k yearly 24d ago
  • Clinical Trial Manager

    Ardelyx, Inc. 4.1company rating

    Waltham, MA Job

    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Purpose of Role: The Clinical Trial Manager is responsible for overseeing all aspects of a clinical trial, from initial planning and design to data analysis and reporting, ensuring the study is conducted ethically, on time, within budget, and in compliance with regulatory standards, while prioritizing patient safety throughout the process. Responsibilities: * Complete project milestones to oversee the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.) * Lead study start-up activities with CROs and clinical sites, including working closely with CRO to complete template clinical documents * Manage the implementation, on-time execution, and conduct of clinical studies, contributing to and tracking milestones, and timelines. * Prepare and/or review/approve study-related documents (e.g., Informed Consent Forms, CRFs, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines) * Implement risk management and mitigation strategies, prioritizing tasks and issues to ensure successful program/study objectives * Participate in activities related to user acceptance testing (UAT) of clinical systems, such as EDC and interactive response technology (IRT) and contribute to authoring system requirements * Manage vendor relationships and contribute to or lead the systems set-up/management, including EDC, IRT, Central Laboratories, and specialty services (ePRO, ECG, etc.) * Track and communicate program/study progress to the Study Lead and Senior Management, with the ability to create and update detailed dashboards and trackers * Represent the department professionally, building and establishing positive relationships with investigators and all other study personnel Qualifications: * Bachelor's degree in Life Sciences, Nursing, or a related field with 5+ years of experience in clinical trial management or related clinical research positions * Master's degree and clinical research certification (e.g., CCRA, CCRP) highly desirable * In-depth knowledge of current clinical trial processes, GCP, and regulatory requirements * Strong project management skills, including managing timelines, budgets, and resources * Excellent communication and leadership skills * Ability to problem-solve and handle complex issues efficiently * Familiarity with clinical trial management software and tools (e.g., EDC systems, eTMF) * May require occasional travel to clinical sites, investigator meetings, and professional meetings * Remote location will be considered but potential for weekly office attendance is preferable (Fremont/Boston) The anticipated annualized base pay range for this full-time position is $126,000-$154,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $126k-154k yearly 20d ago
  • Director, Clinical Operations

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary Tango has a new opportunity to join our growing clinical team as a Director, Clinical Operations. In this new role you will manage at least one oncology trial under the leadership of Tango's VP, Clinical Operations. You will be responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with internal Tango team members, external Clinical Research Organization (CRO) partners, clinical sites and their teams, and third-party vendors. You will thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient. You will be a resource for junior staff, mentoring and/or managing different team members as they grow. The ability to analyze complex issues quickly, to develop relevant and realistic plans and recommendations to implement, is essential. Also necessary are excellent matrix management skills, written and verbal communication skills, attention to detail, and knowledge of quality obligations. Your Role: You will oversee the development of clinical trial project timelines and ensure communication and understanding of risks and challenges; establish plans and monitor metrics; ensure that timelines are accurate and comprehensive Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical trial deliverables Manage clinical trials from start-up through close-out to ensure that both internal and external deliverables are on time and on budget while collaborating across functional areas Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met Maintain partnerships and positive and productive relationships with CRO counterparts; proactively review and identify potential issues or problems with the sites and communicate/escalate to clinical leadership Collaborate with CROs to keep the clinical study database current, accurate, and routinely cleaned Manage the scope of work, change notifications, contract modification, site trial agreements, and other necessary budgetary information for clinical trial operations Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained Additional duties and responsibilities as required What You Bring: BA/BS preferably in nursing, biology, biochemistry or related area (advanced degree desired), with at least 12 years of experience in clinical research operations Minimum of 2 years of oncology experience required, 5+ years preferred Biotechnology experience required Early phase experience, including IND submissions, required Strong vendor management and project management skills are critical Excellent written and oral communication skills Strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required Good organizational/prioritization skills with strong attention to detail Working knowledge of oversight requirements and an eye for quality, required Strong proficiency with MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint, required Collaborative spirit for working positively and effectively with cross-functional teams and partners is essential Travel of up to 25% required We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-HYBRID
    $120k-184k yearly est. 60d+ ago
  • Director, Marketing

    Ardelyx 4.1company rating

    Waltham, MA Job

    Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Director, HCP Marketing - Biotech/Pharmaceutical (Waltham or Northeast Region) Looking for a Marketing ROCKSTAR to join a small, winning Marketing team!! This role will report to the Senior Director of Marketing and will lead all branded healthcare provider (HCP) initiatives in support of the US strategic and tactical plans of IBSRELA. This position requires a highly motivated individual who can effectively work in a fast-paced environment, has a solution-oriented mindset, and is able to execute. The Director, HCP Marketing is responsible for collaborating with multiple cross-functional stakeholders, including but not limited to Medical Affairs, Market Access, Patient Services, Market Research, Sales, Regulatory, Commercial Operations, Legal, and Commercial leadership. This is a great opportunity for candidates looking to work on a broad range of initiatives and gain exposure to company leadership. Responsibilities: Lead the creation and implementation of innovative healthcare provider marketing strategies and tactics across marketing channels (print, digital, SEO/SEM, social media, broadcast, video) Provide strategic oversight and leadership in managing relationships with marketing agencies and key external partners, ensuring seamless execution and optimization of marketing initiatives. Ensure rigorous adherence to regulatory and compliance requirements, proactively navigating Medical, Legal, and Regulatory processes while driving efficiency and innovation in execution. Develop and lead Peer to Peer Program Management (P2P programming, Content, Advisory Boards, Product Theaters, etc.) Develop all aspects of P2P programming, ensuring seamless communications with field team, internal departments, vendors and attendees Drive key opinion leader (KOL) engagement strategies, collaborating with leadership on speaker communications, contracting, and long-term relationship management. Lead the implementation and continuous optimization of peer-to-peer and speaker bureau programs, establishing best-in-class training, compliance oversight, and performance metrics. Develop and implement advanced analytics frameworks for program evaluation, driving data-driven insights and leading quarterly business reviews to assess impact and refine strategies. Own and oversee all peer-to-peer event data and reporting functions, leveraging insights to enhance program effectiveness and demonstrate ROI. Provide strategic direction on the development of marketing materials, ensuring alignment with field teams and headquarters to maximize P2P program engagement. Oversee and optimize digital infrastructure for P2P programming, ensuring seamless access and utilization of resources for internal teams and external stakeholders. Lead financial governance for P2P programs, managing external agencies and ensuring transparent and efficient financial disbursements for speakers and vendors. Foster and strengthen collaborative relationships with key internal stakeholders to ensure success of cross-functional initiatives and long-range plans Partner with sales and commercial leadership to identify market challenges and opportunities, driving strategic solutions, enhanced training, and high-impact messaging to optimize performance. Shape and influence the overall brand strategy, collaborating with marketing leadership to drive execution, innovation, and long-term growth initiatives. Position Requirements: BA/BS, MBA a plus 9-12 years marketing experience with substantial healthcare/pharma/biotech P2P marketing and operational experience Demonstrated ability to think outside the box Excellent analytical and problem-solving skills Combination of strong strategic thinking with ability to execute tactical plans Ability to work well in fast-paced entrepreneurial environment with significant autonomy Strong communication and presentation skills to interface with cross-functional partners and senior management Ability to effectively and consistently execute multiple projects simultaneously Excellent interpersonal, collaboration, and leadership skills Proven track record for consistently meeting or exceeding goals and objectives Ability to travel as required to meet business needs (~30%) Work Environment: Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $219,000 - $267,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $219k-267k yearly 24d ago
  • Manager, Commercial Meetings & Events

    Ardelyx, Inc. 4.1company rating

    Waltham, MA Job

    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The Commercial and Meeting Operations Manager plays a vital role on the Commercial team, ensuring efficient operations for commercial initiatives and internal meetings. This role requires an organized, proactive approach to managing the detailed timelines of events, cross-functional collaboration, and team meeting logistics. Reporting to the Senior Director, Commercial Operations, this position collaborates closely with internal and vendor partners to deliver exceptional event experiences. Responsibilities: * Oversee planning, site selection, logistics, vendor management, and on-site management for Commercial meetings, including sales meetings and events such as the National Meeting * Track and manage budgets for event logistics and associated expenses, coordinating approvals and expense documentation to ensure fiscal accountability * Manage project timelines and maintain alignment across all Commercial functions, based on the strategic plan and tactical objectives by utilizing Smartsheet or similar project management tool * Provide project status updates to stakeholders, providing insights on milestones, timelines, and any adjustments to keep everyone aligned * Manage multiple events with careful attention to timelines, budgets, and logistical details with the ability to manage competing priorities while maintaining a positive and collaborative approach * Work with internal stakeholders across departments and with external partners to achieve shared objectives, fostering positive relationships * Anticipate needs and propose solutions processes to mitigate delays or issues Qualifications: * Bachelor's degree with 5+ years of event planning and logistics or related experience in the pharmaceutical, scientific, or biotech sectors * Event planning certification preferred * Proficient in project management software (e.g., Smartsheet), with strong organizational, multitasking, and communication skills * Detail-oriented, proactive, skilled in relationship management, with a customer-focused mindset * Proficient in project management software (e.g., Smartsheet), Microsoft Excel, and skilled in organization, multitasking, and communication * Dedicated to delivering high-quality experience for both internal colleagues and external stakeholders Work Environment: * Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $106,000-$130,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $44k-60k yearly est. 6d ago
  • Manager, Digital Marketing

    Ardelyx, Inc. 4.1company rating

    Waltham, MA Job

    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Manager, Digital Marketing - Biotech/Pharmaceutical (Waltham or Northeast Region) Purpose of the role: The Digital Marketing Manager will be responsible for executing and optimizing digital marketing strategies across various channels. This individual will leverage their expertise in media execution, omnichannel engagement, and data analysis to drive brand growth, manage external partnerships, and enhance our digital footprint. Key Responsibilities: * Lead digital marketing campaigns across platforms, including Google Ads, LinkedIn, Facebook, and other relevant channels. Ensure alignment with brand goals and compliance with industry regulations. * Oversee SEO and SEM initiatives, including keyword research, content optimization, and performance tracking, to enhance organic and paid search presence. * Coordinate and manage multiple campaigns and projects, collaborating with cross-functional teams and external partners. Ensure on-time, on-budget delivery of digital marketing assets, websites, social media posts, and CRM emails. * Analyze internal and external data to assess campaign effectiveness, generate insights, and provide actionable recommendations. Define and track key performance indicators (KPIs) and adjust strategies as needed to optimize ROI. * Partner with external agencies and vendors to drive digital tactics, including patient and healthcare professional (HCP) websites, digital media, social channels, and CRM email campaigns. Monitor performance to ensure partners meet objectives and deliver high-quality work. * Identify and implement digital enhancements based on data insights and industry best practices. Continuously monitor and refine campaign elements to improve engagement and achieve digital marketing goals. Position Requirements: * Requires a bachelor's degree in Marketing, Communications, Business, or a related field. * 3-5+ years of experience in digital marketing, preferably in the pharmaceutical or healthcare industry, with a focus on media execution and omnichannel engagement. * Proven track record in managing digital campaigns across platforms such as Google Ads, LinkedIn, and Facebook. Proficiency in SEO/SEM principles, including keyword research and content optimization. * Strong organizational skills with the ability to manage multiple projects simultaneously. * Ability to interpret complex data sets and derive actionable insights that align with business objectives. * Excellent written and verbal communication skills, with a talent for presenting data and insights in a clear, compelling manner. * Experience with media, buying and planning, understanding omni-channel, ecosystem, decipher marketing analytics to help make effective marketing decisions, understands media, media execution. * Ability to work collaboratively and manage multiple projects simultaneously. * Ability to travel up to 10-15% The anticipated annualized base pay range for this full-time position is $116,362 - 129,291. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $116.4k-129.3k yearly 43d ago
  • Clinical Research Associate

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary Tango has an exciting new opportunity to join our growing Clinical team as our first in-house Clinical Research Associate (CRA). In this role you will be responsible for effective partnership with our full service CRO for their management and oversite of assigned clinical studies to ensure data quality and patient safety in accordance with ICH-GCP guidelines and local regulations, as well as applicable SOPs. You will collaborate with the clinical teams in supporting the day-to-day clinical study activities. Your Role: Partner with our full service CRO in their contracted monitoring of our trials, ensuring compliance, data currency and relationship maintenance with sites Conduct site visits to determine protocol and regulatory compliance, and prepare and maintain required documentation Develop collaborative relationships with sites and study vendors Provide support to the clinical study manager, assist with monitoring visit report review and other aspects Develop study-specific monitoring tools to be used by the monitoring team to assist with study data review Track enrollment status reports to ensure study sites stay on track to meet enrollment goals Provide support for study sites with audits/inspections and preparation/responses and quality issues as needed Review outstanding data reports to ensure data collection timelines are met Perform Serious Adverse Event reconciliation and work with study sites to resolve discrepancies Collaborate with others in a mutually supportive and cooperative manner assisting others when possible, to achieve study and project goals Additional duties and responsibilities as required What You Bring: Bachelor's degree required with 6 years industry experience in clinical trials At least 3 years' monitoring experience At least 2 years' oncology monitoring experience Experience supporting multiple complicated oncology studies simultaneously Proven ability to develop relationships with investigator sites and vendors Excellent working knowledge of ICH/GCP and relevant regulations High attention to detail with a focus on quality and compliance in all aspects Ability to travel as needed, up to 50% Experience with Microsoft Office suite, EDC, CTMS, eTMF and other technologies We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $66k-103k yearly est. 37d ago
  • Senior Manager, HCP Marketing

    Ardelyx, Inc. 4.1company rating

    Waltham, MA Job

    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. We are seeking a dynamic and experienced Senior Manager, HCP Marketing to join our Marketing team. This role will report to the Director of Marketing and will play a key role in driving healthcare provider-facing marketing initiatives for the promotion of IBSRELA. This position requires a highly motivated individual who can effectively work in a fast-paced environment, has a solution-oriented mindset, and is able to execute. Responsibilities: * Develop and implement innovative marketing tactics to engage HCPs across multiple channels (print, digital, SEO/SEM, social media, broadcast, video) * Execute multiple, simultaneous projects ensuring deliverables are on time and on budget * Lead the planning, execution, and follow-up of regional and local healthcare provider-facing conferences, ensuring alignment with the overall brand strategy * Lead and manage the field advisory team to garner insights to inform and evolve field-facing tactics * Oversee the maintenance and management of print materials warehouse, ensuring materials are up-to-date, compliant, and readily available for field teams * Collaborate with multiple functional groups within the organization, including but not limited to Field Sales, Medical Affairs, Market Access, Compliance, Legal and Regulatory Affairs * Manage project timelines, including development of work plans and routing of all promotional materials through the appropriate review channels * Partner with external agencies and vendors Qualifications: * Bachelor's degree in Marketing or related field (Advanced degree preferred) with 8+ years of marketing experience in healthcare/pharma/biotech or equivalent, with a strong track record in campaign development and execution * Strong communication, project management, and analytical skills. Experience with digital marketing tools and HCP engagement strategies * Strong presentation skills to interface with cross-functional partners and senior management * P2P marketing and operational experience * Demonstrated ability to think outside the box * Excellent analytical and problem-solving skills * Ability to work well in fast-paced entrepreneurial environment with significant autonomy * Ability to effectively and consistently execute multiple projects simultaneously * Excellent interpersonal, collaboration, and leadership skills Work Environment: * Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $148,000 - $180,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $148k-180k yearly 2d ago
  • Associate Director, Business Analytics

    Ardelyx 4.1company rating

    Waltham, MA Job

    Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Associate Director, Business Analytics Job Summary The Associate Director, Business Analytics will be responsible for strategic reporting and key insight generation for the Ardelyx portfolio of products. This individual will be responsible for staging large amounts of data into digestible tables for systems integration, developing dynamic data dashboards that can adjust with real-time data, and articulating trends and insights into clear & specific action items to ensure optimized commercial uptake for IBSRELA and XPHOZAH . The candidate will work in a highly cross-functional environment interfacing with the Commercial Market Access, Sales, and Marketing teams. The successful commercial execution of these functions will be highly dependent upon the analytic deliverables and strategic guidance provided by this individual. The person in this role should be very analytic, energetic, confident, collaborative, diplomatic, and a problem solver who takes ownership of the important role they will play to achieve the shared business objectives of the organization. This role will report to the Executive Director, Business Analytics. If you'd like to help establish Ardelyx as a leading company in the biopharma industry, one that advances patient care with novel therapies that meet important clinical needs, come join us! Responsibilities Collaborate with external business partners and internal Ardelyx stakeholders to create user-friendly, intuitive, & interactive data visualizations and dashboards within BI platforms (including Tableau & Power BI) that will garner insights and drive business decisions. Establish formal policies and outline documentation for commercial data governance and stewardship including data dictionary, business rules, process flows and establishment of policies and procedures to maintain integrity of data and ensure compliance with AMA and other regulations. Serve as the primary contact with external data warehouse vendor (Beghou) to ensure that disparate data tables are staged cohesively and adhere to set business rules. Work closely with IT counterparts to gather and define business requirements for field and HQ reporting needs. Test any new functionality to ensure it meets the stated business needs. Work with legal and compliance to understand data trends and ensure compliance to all regulations and policies. Serve as the primary field facing contact to address all ad hoc analytic related queries. This includes requests related to sales performance, incentive compensation, HCP universe, call & sample activity and general reporting requests. Partner with key commercial stakeholders, including market access & sales and marketing team to define performance metrics, automate information flow, and continuously enhance reports as the business evolves. Examples include sales team performance, activity analysis, territory planning, and sales and marketing initiative tracking. Qualifications: Bachelor's degree required; MBA or other advanced degree preferred At least 8+ years' experience working with life science related data analytics, data warehousing & database management; must have direct experience with life sciences data sets including IQVIA, Symphony, and claims data Expertise with BI platforms (Tableau, Power BI), MS programs (Excel, PowerPoint) and data cloud platforms (Snowflake) Extremely detail oriented & demonstrate problem solving/resolution skills Aptitude to compile, analyze and present data in a concise manner and translate analysis into actionable insights and recommendations in both written and oral contexts for technical and non-technical stakeholders Have familiarity in working with complex data sets and building automated processes Demonstrate the ability to take initiative and work independently in a lean, dynamic, and nimble environment Ability to work in a fast-paced environment and adjust to changing priorities Capability to work on multiple projects and meet timelines Effective interpersonal and collaboration skills; ability to develop rapport and credibility with market access, sales, and marketing teams, (both field and office based), as well as senior management stakeholders Excellent written and oral communication skills; comfortable delivering presentations to a wide range of stakeholders including executive leadership teams Comfortable with ambiguity; can drive towards implementation in a fast-paced and evolving environment The anticipated annualized base pay range for this full-time position is $161,612-$197,526. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $161.6k-197.5k yearly 24d ago
  • Senior Clinical Research Associate

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary Tango has an exciting new opportunity to join our growing Clinical team as our first in-house Clinical Research Associate (CRA). In this role you will be responsible for effective partnership with our full service CRO for their management and oversite of assigned clinical studies to ensure data quality and patient safety in accordance with ICH-GCP guidelines and local regulations, as well as applicable SOPs. You will collaborate with the clinical teams in supporting the day-to-day clinical study activities. Your Role: * Partner with our full service CRO in their contracted monitoring of our trials, ensuring compliance, data currency and relationship maintenance with sites * Conduct site visits to determine protocol and regulatory compliance, and prepare and maintain required documentation * Develop collaborative relationships with sites and study vendors * Provide support to the clinical study manager, assist with monitoring visit report review and other aspects * Develop study-specific monitoring tools to be used by the monitoring team to assist with study data review * Track enrollment status reports to ensure study sites stay on track to meet enrollment goals * Provide support for study sites with audits/inspections and preparation/responses and quality issues as needed * Review outstanding data reports to ensure data collection timelines are met * Perform Serious Adverse Event reconciliation and work with study sites to resolve discrepancies * Collaborate with others in a mutually supportive and cooperative manner assisting others when possible, to achieve study and project goals * Additional duties and responsibilities as required What You Bring: * Bachelor's degree required with 6 years industry experience in clinical trials * At least 3 years' monitoring experience * At least 2 years' oncology monitoring experience * Experience supporting multiple complicated oncology studies simultaneously * Proven ability to develop relationships with investigator sites and vendors * Excellent working knowledge of ICH/GCP and relevant regulations * High attention to detail with a focus on quality and compliance in all aspects * Ability to travel as needed, up to 50% * Experience with Microsoft Office suite, EDC, CTMS, eTMF and other technologies We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $75k-119k yearly est. 6d ago
  • Director, Marketing

    Ardelyx, Inc. 4.1company rating

    Waltham, MA Job

    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Director, HCP Marketing - Biotech/Pharmaceutical (Waltham or Northeast Region) Looking for a Marketing ROCKSTAR to join a small, winning Marketing team!! This role will report to the Senior Director of Marketing and will lead all branded healthcare provider (HCP) initiatives in support of the US strategic and tactical plans of IBSRELA. This position requires a highly motivated individual who can effectively work in a fast-paced environment, has a solution-oriented mindset, and is able to execute. The Director, HCP Marketing is responsible for collaborating with multiple cross-functional stakeholders, including but not limited to Medical Affairs, Market Access, Patient Services, Market Research, Sales, Regulatory, Commercial Operations, Legal, and Commercial leadership. This is a great opportunity for candidates looking to work on a broad range of initiatives and gain exposure to company leadership. Responsibilities: * Lead the creation and implementation of innovative healthcare provider marketing strategies and tactics across marketing channels (print, digital, SEO/SEM, social media, broadcast, video) * Provide strategic oversight and leadership in managing relationships with marketing agencies and key external partners, ensuring seamless execution and optimization of marketing initiatives. * Ensure rigorous adherence to regulatory and compliance requirements, proactively navigating Medical, Legal, and Regulatory processes while driving efficiency and innovation in execution. * Develop and lead Peer to Peer Program Management (P2P programming, Content, Advisory Boards, Product Theaters, etc.) * Develop all aspects of P2P programming, ensuring seamless communications with field team, internal departments, vendors and attendees * Drive key opinion leader (KOL) engagement strategies, collaborating with leadership on speaker communications, contracting, and long-term relationship management. * Lead the implementation and continuous optimization of peer-to-peer and speaker bureau programs, establishing best-in-class training, compliance oversight, and performance metrics. * Develop and implement advanced analytics frameworks for program evaluation, driving data-driven insights and leading quarterly business reviews to assess impact and refine strategies. * Own and oversee all peer-to-peer event data and reporting functions, leveraging insights to enhance program effectiveness and demonstrate ROI. * Provide strategic direction on the development of marketing materials, ensuring alignment with field teams and headquarters to maximize P2P program engagement. * Oversee and optimize digital infrastructure for P2P programming, ensuring seamless access and utilization of resources for internal teams and external stakeholders. * Lead financial governance for P2P programs, managing external agencies and ensuring transparent and efficient financial disbursements for speakers and vendors. * Foster and strengthen collaborative relationships with key internal stakeholders to ensure success of cross-functional initiatives and long-range plans * Partner with sales and commercial leadership to identify market challenges and opportunities, driving strategic solutions, enhanced training, and high-impact messaging to optimize performance. * Shape and influence the overall brand strategy, collaborating with marketing leadership to drive execution, innovation, and long-term growth initiatives. Position Requirements: * BA/BS, MBA a plus * 9-12 years marketing experience with substantial healthcare/pharma/biotech * P2P marketing and operational experience * Demonstrated ability to think outside the box * Excellent analytical and problem-solving skills * Combination of strong strategic thinking with ability to execute tactical plans * Ability to work well in fast-paced entrepreneurial environment with significant autonomy * Strong communication and presentation skills to interface with cross-functional partners and senior management * Ability to effectively and consistently execute multiple projects simultaneously * Excellent interpersonal, collaboration, and leadership skills * Proven track record for consistently meeting or exceeding goals and objectives * Ability to travel as required to meet business needs (~30%) Work Environment: * Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $219,000 - $267,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $219k-267k yearly 41d ago
  • Manager, Digital Marketing

    Ardelyx 4.1company rating

    Waltham, MA Job

    Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Manager, Digital Marketing - Biotech/Pharmaceutical (Waltham or Northeast Region) Purpose of the role: The Digital Marketing Manager will be responsible for executing and optimizing digital marketing strategies across various channels. This individual will leverage their expertise in media execution, omnichannel engagement, and data analysis to drive brand growth, manage external partnerships, and enhance our digital footprint. Key Responsibilities: Lead digital marketing campaigns across platforms, including Google Ads, LinkedIn, Facebook, and other relevant channels. Ensure alignment with brand goals and compliance with industry regulations. Oversee SEO and SEM initiatives, including keyword research, content optimization, and performance tracking, to enhance organic and paid search presence. Coordinate and manage multiple campaigns and projects, collaborating with cross-functional teams and external partners. Ensure on-time, on-budget delivery of digital marketing assets, websites, social media posts, and CRM emails. Analyze internal and external data to assess campaign effectiveness, generate insights, and provide actionable recommendations. Define and track key performance indicators (KPIs) and adjust strategies as needed to optimize ROI. Partner with external agencies and vendors to drive digital tactics, including patient and healthcare professional (HCP) websites, digital media, social channels, and CRM email campaigns. Monitor performance to ensure partners meet objectives and deliver high-quality work. Identify and implement digital enhancements based on data insights and industry best practices. Continuously monitor and refine campaign elements to improve engagement and achieve digital marketing goals. Position Requirements: Requires a bachelor's degree in Marketing, Communications, Business, or a related field. 3-5+ years of experience in digital marketing, preferably in the pharmaceutical or healthcare industry, with a focus on media execution and omnichannel engagement. Proven track record in managing digital campaigns across platforms such as Google Ads, LinkedIn, and Facebook. Proficiency in SEO/SEM principles, including keyword research and content optimization. Strong organizational skills with the ability to manage multiple projects simultaneously. Ability to interpret complex data sets and derive actionable insights that align with business objectives. Excellent written and verbal communication skills, with a talent for presenting data and insights in a clear, compelling manner. Experience with media, buying and planning, understanding omni-channel, ecosystem, decipher marketing analytics to help make effective marketing decisions, understands media, media execution. Ability to work collaboratively and manage multiple projects simultaneously. Ability to travel up to 10-15% The anticipated annualized base pay range for this full-time position is $116,362 - 129,291. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $116.4k-129.3k yearly 24d ago
  • Associate Director, Clinical Data Management

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary: Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango's clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling. Your role: Lead the clinical data management partnership with CROs, ensuring seamless execution of Tango's clinical trials Provide oversight for fully outsourced data management activities from RFP to final database lock, working closely with CROs to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools Develop and/or author key data management documents, including database design specifications, edit checks, CRF completion guidelines, and Data Management Plans, ensuring compliance with CDASH and SDTM standards Partner with cross-functional teams to standardize data collection and reporting processes, enhancing efficiency and data quality Collaborate with internal and external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure projects are delivered on time and within budget Participate in study team meetings, providing updates, addressing issues, and ensuring data is effectively collected, reviewed, and analyzed Work closely with cross-functional teams to ensure clinical data is optimized for early-phase deliverables and downstream analysis This role is ideal for someone who thrives in a dynamic environment, excels at collaboration, and is passionate about ensuring high-quality clinical data to drive impactful decision-making What you bring: Bachelor's degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms 5-8 years of management experience in clinical data management, most of which should be in industry and preferably across therapeutic areas including oncology Strong vendor management and oversight experience Solid technical skills across data platforms; programming experience preferred Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data Experience in regulatory GCP inspections/audits preferred Experience with Spotfire, eLuminate or other data visualization software Ability to manage multiple projects in a fast-paced environment We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $112k-168k yearly est. 5d ago
  • Clinical Trial Associate

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary In this exciting new role, you will provide clinical trial coordination support to the assigned clinical trial or trials. This support includes study deliverable tracking and completion of study documentation including eTMF is maintained for the assigned clinical trial(s). You will work with internal clinical team members and with external vendors and CROs. The position reports to the Clinical Operations Program Lead. May work collaboratively on one program or across several trials to support clinical operations activities. Your Role: * You will coordinate support from start up to close out for assigned trials * Ongoing eTMF maintenance and completion with CRO for assigned trials * Meeting coordination and documentation * Tracking of action items for clinical deliverables * Reconciliation and tracking of purchase orders and invoices for assigned trials * Daily study management for assigned clinical trial(s) or assigned region in larger studies * Ownership of clinical trial tracking documents * May include clinical sample tracking and coordination * Ensure trial management documentation is conducted in accordance with ICH/GCP standards * Develop and maintain strong, collaborative relationships with multiple cross functional team members * Additional duties and responsibilities as required What You Bring: * At least 2 years of trial coordination experience in a clinical research environment, with at least some within the biotech/pharma industry * Bachelor's Degree in a life-science-based subject * Oncology therapeutic experience preferred * Basic understanding of drug development * Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies * Good verbal and written communication skills * Good organizational skills and attention to detail We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Hybrid
    $82k-135k yearly est. 4d ago
  • Associate Director, Marketing (Nephrology)

    Ardelyx 4.1company rating

    Waltham, MA Job

    Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Associate Director, Marketing - Biotech/Pharmaceutical (Waltham or Northeast Region) Purpose of the role: Looking for a Marketing ROCKSTAR to join a small, winning Marketing team!! This role will report to the Director of Marketing and will contribute and lead key initiatives in support of the US strategic and tactical plans for the launch of XPHOZAH. This position requires a highly motivated individual who can effectively work in a fast-paced environment, has a solution-oriented mindset, and is able to execute. The Associate Director, Marketing is responsible for collaborating with multiple cross-functional stakeholders, including but not limited to Medical Affairs, Market Access, Sales, Regulatory, Commercial Operations, Legal, and Commercial leadership. This is a great opportunity for candidates looking to be part of a product launch, work on a broad range of initiatives, and gain exposure to company leadership. Lead the creation and implementation of innovative healthcare provider marketing strategies and tactics across marketing channels (print, digital, SEO/SEM, social media, broadcast, video) Lead for Peer to Peer Program Management (P2P programming, Content, Advisory Boards, Product Theaters, etc.) Manage all aspects of P2P programming including communications with field team, internal departments, vendors and attendees Collaborate with KOL lead on communications to speakers and contracting Organize and manage implementation of peer to peer and speaker bureau programs, and related training, ensuring compliance with company policies, standard procedures and business rules Implement metrics plans and optimization; manage quarterly business reviews of programs Own the peer-to-peer event data for reporting with agency Create marketing materials for the field teams/HQ to promote the programs Oversee and manage Rep portal for P2P programming Oversee agency that handle financial disbursements to speakers and vendors for programs Manage relationships with marketing agencies/partners Develop and maintain positive and collaborative working relationships with a broad range of internal stakeholders to ensure success of cross-functional initiatives and long-range plans Work closely with sales and sales leadership team to understand market challenges and provide/adapt strategies, tools, training, and messages to drive success Collaborate with marketing team on overall brand strategy and execution of tactics Position Requirements: BA/BS, MBA a plus 5-10 years marketing experience with substantial healthcare/pharma/biotech Launch experience a plus P2P marketing and operational experience Demonstrated ability to think outside the box Excellent analytical and problem-solving skills Combination of strong strategic thinking with ability to execute tactical plans Ability to work well in fast-paced entrepreneurial environment with significant autonomy Strong communication and presentation skills to interface with cross-functional partners and senior management Ability to effectively and consistently execute multiple projects simultaneously Excellent interpersonal, collaboration, and leadership skills Proven track record for consistently meeting or exceeding goals and objectives Ability to travel as required to meet business needs (~30%) Work Environment: Hybrid corporate office and remote-based position, Boston area preferred The anticipated annualized base pay range for this full-time position is $161,325 - $197,175. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
    $161.3k-197.2k yearly 24d ago
  • Senior Director, Biostatistics

    Tango Therapeutics 4.6company rating

    Boston, MA Job

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. Tango's labs and offices are currently located at 201 Brookline Avenue, in the vibrant Fenway neighborhood of Boston. Summary Reporting to the Vice President, Biometrics you will be working with cross‑functional clinical teams responsible for statistical activities across Tango's clinical programs, including overseeing statistical deliverables outsourced to clinical CROs. This is an exciting opportunity to make an impact in the development of transformative therapies that may change patients' lives. The ideal candidate is a good communicator, collaborative, self-motivated, and forward‑thinking. Your Role: You will serve as a biostatistics expert for Tango's clinical programs Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies As a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverables Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses Provide statistical input for clinical documents Perform QC/QA of statistical deliverables including validation of key analysis results Perform ad hoc statistical analyses as needed Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results Accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions; provide thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards Represent Tango regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners Support inspection readiness activities as needed Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development Additional duties and responsibilities as required What You Bring: PhD in statistics or related discipline; MS with appropriate years of directly relevant experience At least 12 years' experience in the pharmaceutical or biotech industry Oncology experience required Experience in the design, analysis, and reporting of clinical trials Experience in INDs, NDAs, MAAs, or other regulatory submissions In-depth knowledge of statistical methods for clinical trials Knowledge of FDA, EMA, and ICH regulations and guidelines Proficient in statistical programming (SAS and R) Ability to lead statistical efforts for multiple studies Fluent in data standards, including SDTM and ADaM Experience in outsourced statistical services provided by CROs Ability to work independently and act with initiative to address issues Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Hybrid
    $132k-194k yearly est. 60d+ ago

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