Sr. Medical Director, Drug Safety & Pharmacovigilance
Scholar Rock
June 27, 2026
Remote friendly (Cambridge, MA)
United States
Medical Affairs
Summary of Position:
The Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy and expertise across pre- and post-approval for assigned products. Drives proactive implementation of risk management initiatives in line with global regulatory requirements, including continuous evaluation of safety data and signal detection/management.
Position Responsibilities:
- Lead and support development of pharmacovigilance strategies to ensure compliance with clinical development and commercial goals.
- Oversee and conduct signal detection: monitor, evaluate, interpret, manage, and communicate safety information.
- Oversee Product Safety Committee (PSC) meetings; evaluate risk-benefit and escalate safety issues to the Executive Safety Committee.
- Perform medical safety review and causality assessment across pre-clinical, clinical, post-marketing, and literature data.
- Provide medical expert safety input into critical documents (INDs/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Oversee aggregate reports and signal evaluation reports.
- Provide clinical content for regulatory safety inquiries.
- Lead CRO staff/oversight for outsourced medical activities; collaborate with internal safety scientists.
- Assist with SOP writing/development to ensure regulatory compliance.
- Plan and execute external and internal stakeholder meetings (e.g., DMCs, vendor oversight).
- Support process improvement and functional training; ensure ethical and professional standards and compliance with policies and regulations.
Candidate Requirements:
- MD/MBBS/MD-PhD (or equivalent).
- 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience.
- Strong US and EU pharmacovigilance regulatory knowledge.
- Experience supporting drug safety in registrational clinical studies.
- Medical competence; scientific analysis and reasoning.
- Knowledge of drug development from discovery through registration and post-marketing.
- IND experience; NDA/BLA submission and regulatory interaction experience highly desirable.
- Proven results in matrix with leadership and presentation skills; translating data into clinical strategies.
Compensation:
- $280,000 - $420,000 a year
The Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy and expertise across pre- and post-approval for assigned products. Drives proactive implementation of risk management initiatives in line with global regulatory requirements, including continuous evaluation of safety data and signal detection/management.
Position Responsibilities:
- Lead and support development of pharmacovigilance strategies to ensure compliance with clinical development and commercial goals.
- Oversee and conduct signal detection: monitor, evaluate, interpret, manage, and communicate safety information.
- Oversee Product Safety Committee (PSC) meetings; evaluate risk-benefit and escalate safety issues to the Executive Safety Committee.
- Perform medical safety review and causality assessment across pre-clinical, clinical, post-marketing, and literature data.
- Provide medical expert safety input into critical documents (INDs/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Oversee aggregate reports and signal evaluation reports.
- Provide clinical content for regulatory safety inquiries.
- Lead CRO staff/oversight for outsourced medical activities; collaborate with internal safety scientists.
- Assist with SOP writing/development to ensure regulatory compliance.
- Plan and execute external and internal stakeholder meetings (e.g., DMCs, vendor oversight).
- Support process improvement and functional training; ensure ethical and professional standards and compliance with policies and regulations.
Candidate Requirements:
- MD/MBBS/MD-PhD (or equivalent).
- 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience.
- Strong US and EU pharmacovigilance regulatory knowledge.
- Experience supporting drug safety in registrational clinical studies.
- Medical competence; scientific analysis and reasoning.
- Knowledge of drug development from discovery through registration and post-marketing.
- IND experience; NDA/BLA submission and regulatory interaction experience highly desirable.
- Proven results in matrix with leadership and presentation skills; translating data into clinical strategies.
Compensation:
- $280,000 - $420,000 a year