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New · posted Oct 31

Crescent Biopharma · Biotechnology

Vice President, Pharmacovigilance

  • Waltham, MA
  • Hybrid
  • Full-time
  • VP & Executive
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Pay$323K–$357K
EmploymentFull-time
LocationWaltham, MA
LevelVP & Executive
FunctionClinical Safety & Pharmacovigilance
DeadlineOpen until filled

The role

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a strategic leader, Vice President of Pharmacovigilance to lead patient safety and pharmacovigilance needs, fostering a culture where safety is integrated into every aspect of our drug development process. This role may be based in a hybrid capacity from our Waltham, MA office or remotely from the East Coast. Reporting directly to the Chief Medical Officer (CMO), you will be leading and building out the Safety and PV. This includes being responsible for the strategic oversight and execution of all safety and pharmacovigilance activities, ensuring compliance with global regulatory standards.

As the VP, Head of Safety and Pharmacovigilance, you will lead our efforts in ensuring the safety of our investigational products. This involves providing strategic medical oversight, managing safety data, and guiding cross-functional collaboration to integrate safety into all phases of our product lifecycle. You will be responsible for creating and building the function. Your role will include interacting with regulatory authorities, leading the pharmacovigilance team, and overseeing the activities of external safety service providers. This role is based in Waltham, MA and you must have experience in the oncology space.

What you need

  • M.D., D.O., or M.B.B.S. required.
  • 15+ years of global experience in oncology drug safety within the biotechnology or pharmaceutical industry.
  • BLA/NDA experience highly preferred 
  • In-depth knowledge of FDA safety regulations, ICH Guidelines, NMPA, and other global safety regulations.
  • Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance
  • Expert knowledge of safety database applications (e.g., Veeva, ARGUS, IQVIA) and safety signal detection.
  • Strong leadership skills with the ability to mentor teams and lead cross-functional initiatives.
  • Excellent written, verbal, and presentation skills, with the ability to influence senior leadership and external stakeholders.

    • Skills named in this posting

    What you'll do

  • Lead and build our Safety and Pharmacovigilance function
  • Establish and maintain a safety and pharmacovigilance infrastructure that prioritizes “safety by design” in all development activities.
  • Lead all pharmacovigilance activities for our products, including safety surveillance, signal detection, and risk-benefit assessments.
  • Serve as the primary contact for safety-related issues, including regulatory authority interactions and safety service provider management.
  • Provide strategic safety insights to the CMO and Executive Leadership Team, particularly regarding the risk-benefit profile of company products.
  • Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation.
  • Serve as the primary PV representative in interactions with FDA, NMPA, EMA, and other global health authorities, including Type B/C meetings, Health Authority safety queries, and pharmacovigilance inspections.
  • Ensure compliance with global safety regulations and guidelines and lead responses to safety-related inquiries from regulatory authorities.
  • Manage the pharmacovigilance budget and resources, including both internal teams and external contractors.
  • Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits.
  • Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality, to integrate safety considerations into company strategy.
  • Represent the company, externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities.

    • Pay

    $323,000 – $357,000 a year

    Employer provided
    How this compares

  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
  • Competitive compensation, including base salary, performance bonus, and equity
  • 100% employer-paid benefits package
  • Flexible PTO; also, two, one-week company-wide shutdowns each year
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities

    • Where you'll work

    Waltham, MAHybridOpen in Maps (opens in a new tab)

    More jobs in Waltham, MA
    Equal opportunity, accessibility and legal noticesCrescent Biopharma's statements, word for word

    Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

    Job intelligence

    The context around this role

    Live data · October 31, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 2% below the US median for Clinical Safety & Pharmacovigilance roles at this level.

    This roleEmployer provided

    $323,000 to $357,000 a year

    VP & Executive roles in the US10 roles publishing pay

    Middle half $346,500 to $353,125, median $346,500
    Annual base pay
    Annual base payLowMedianHigh
    This role$323,000—$357,000
    All US$346,500$346,500$353,125

    This role: Crescent Biopharma's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Clinical Safety & Pharmacovigilance

    The general path across 113 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Crescent Biopharma's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Associate, Pharmacovigilance Operations/Drug Safety · Clinical Sciences Partnership COE Coordinator

      5 open

    2. Earlier

      Senior & Principal

      Often: Senior Safety Scientist · Clinical FSP Quality Manager

      $186K median11 open

    3. Earlier

      Manager

      Often: Senior Manager, Clinical Quality Assurance · Clinical FSP Quality Manager

      $170K median15 open

    4. One step back

      Director

      Often: Director · Senior Medical Director

      $260K median70 open

    5. This role

      VP & Executive

      Often: Head of Multiple Myeloma & AML, Oncology · Head of Patient-Facing Quality Assurance

      $347K median12 open

    Skills DNA

    What this role leans on

    How many of the posting's 5 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 3 linesDocumentation and SOPs: 1 lineInvestigations and CAPA: 1 lineRegulatory submissions: 2 linesQuality systems and risk: 1 lineData and digital systems: 1 lineClinical trial conduct: 1 lineCollaboration and leadership: 5 linesGMPDocumentationInvestigationsSubmissionsQuality systemsData systemsClinical trialsTeamwork
    • Collaboration and leadership5
    • GMP and compliance3
    • Regulatory submissions2
    • Documentation and SOPs1
    • Investigations and CAPA1
    • Quality systems and risk1
    • Data and digital systems1
    • Clinical trial conduct1

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    From Regulatory News

    Manufacturing and quality coverage for this profession

    Company hiring pulse

    Crescent Biopharma on Regulatory Jobs

    3
    Open roles
    3
    Distinct roles
    1
    Locations

    By discipline

    • Regulatory1 33%
    • Quality1 33%
    • Clinical1 33%

    By level

    • Director2 67%
    • VP & Executive1 33%
    See all 3 Crescent Biopharma roles

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    Similar Clinical Safety & Pharmacovigilance roles elsewhere

    Vice President, Pharmacovigilance at Crescent Biopharma

    Open until filled. $323K–$357K a year, employer provided.

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