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New · posted Oct 31

Scholar Rock · Biotechnology

Sr. Medical Director, Drug Safety & Pharmacovigilance

  • Cambridge, MA
  • Hybrid
  • Full-time
  • Director
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Pay$280K–$420K
EmploymentFull-time
LocationCambridge, MA
LevelDirector
FunctionClinical Safety & Pharmacovigilance
DeadlineOpen until filled

The role

Summary of Position

The Sr. Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise, and guidance, pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will work closely with cross functional teams and Departments for achieving project goals, within timelines & with high quality.

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

What you need

Candidate Requirements

  • MD or MBBS or MD-PhD or equivalent medical degree
  • 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
  • Strong understanding of pharmacovigilance regulations in the US and EU.
  • Experience in supporting drug safety activities in registrational clinical studies
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals
  • Demonstrated skills in scientific analysis and reasoning.
  • Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
  • Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
  • Strong track record of delivering results through effective team and peer leadership in matrix
  • Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.

    • Skills named in this posting

    What you'll do

  • Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals.
  • Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management and communication of safety information.
  • Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams. Escalate and present safety issues to the Executive Safety Committee.
  • Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
  • Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
  • Oversight of aggregate reports and signal evaluation reports for assigned projects.
  • Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
  • Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight of outsourced Medical activities, as applicable.
  • Oversee and collaborate with internal safety scientists within TA
  • Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws.
  • Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.)
  • Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Support process improvement and functional training at departmental & company level
  • Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of work.
  • Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations

    • Pay

    $280,000 – $420,000 a year

    Employer provided
    How this compares

    Where you'll work

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

    More jobs in Cambridge, MA
    Equal opportunity, accessibility and legal noticesScholar Rock's statements, word for word

    Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

    Job intelligence

    The context around this role

    Live data · October 31, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 35% above the US median for Clinical Safety & Pharmacovigilance roles at this level.

    This roleEmployer provided

    $280,000 to $420,000 a year

    Director roles in Massachusetts24 roles publishing pay

    Middle half $217,500 to $281,000, median $229,000

    Director roles in the US69 roles publishing pay

    Middle half $213,500 to $281,000, median $260,000
    Annual base pay
    Annual base payLowMedianHigh
    This role$280,000—$420,000
    Massachusetts$217,500$229,000$281,000
    All US$213,500$260,000$281,000

    This role: Scholar Rock'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 Scholar Rock'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. One step back

      Manager

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

      $170K median15 open

    4. This role

      Director

      Often: Director · Senior Medical Director

      $260K median70 open

    5. Next step

      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: 2 linesLab testing and methods: 1 lineDocumentation and SOPs: 2 linesRegulatory submissions: 2 linesQuality systems and risk: 2 linesClinical trial conduct: 2 linesCollaboration and leadership: 4 linesGMPLab testingDocumentationSubmissionsQuality systemsClinical trialsTeamwork
    • Collaboration and leadership4
    • GMP and compliance2
    • Documentation and SOPs2
    • Regulatory submissions2
    • Quality systems and risk2
    • Clinical trial conduct2
    • Lab testing and methods1

    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

    Scholar Rock on Regulatory Jobs

    6
    Open roles
    6
    Distinct roles
    1
    Locations

    By discipline

    • Clinical3 50%
    • Regulatory2 33%
    • Quality1 17%

    By level

    • Director5 83%
    • VP & Executive1 17%
    See all 6 Scholar Rock roles

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    All 6 Scholar Rock roles

    Similar Clinical Safety & Pharmacovigilance roles elsewhere

    Sr. Medical Director, Drug Safety & Pharmacovigilance at Scholar Rock

    Open until filled. $280K–$420K a year, employer provided.

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