Senior Medical Director - Drug Safety & Pharmacovigilance

1w1 week ago

Scholar Rock

Cambridge, US · Full-time · $275,000 – $375,000

About this role

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for serious diseases with high unmet need. Focused on the TGFβ superfamily, it advances treatments for neuromuscular disease, cardiometabolic disorders, and cancer. The Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy, expertise, and guidance pre- and post-approval.

This key position drives proactive implementation of risk management initiatives per global regulatory requirements. Core responsibilities include continuous evaluation of safety data, signal detection, and management of the compound's safety profile. The role ensures efficient safety oversight throughout drug development.

Works closely with cross-functional teams to achieve project goals within timelines and with high quality. Oversees Product Safety Committee meetings to evaluate risk-benefit, escalating issues to the Executive Safety Committee. Collaborates on medical safety reviews from pre-clinical, clinical, and post-marketing sources.

Provides input into critical documents like INDs, protocols, ICFs, IBs, and CSRs. Leads oversight of aggregate and signal evaluation reports, and authors clinical content for regulatory responses. Impacts the lifecycle of innovative protein growth factor-targeted therapies.

Requirements

Medical degree (MD or equivalent) with expertise in drug safety
In-depth knowledge of pharmacovigilance strategies and global regulatory requirements
Experience in signal detection, evaluation, and risk management
Proficiency in causality assessment of safety data from diverse sources
Ability to lead Product Safety Committee and Executive Safety Committee interactions
Familiarity with ICH guidelines and safety reporting standards
Skills in reviewing aggregate safety reports and regulatory submissions
Cross-functional collaboration in clinical development environments

Responsibilities

Lead and support development of pharmacovigilance strategies for products within therapeutic area to ensure compliance with corporate goals
Conduct signal detection activities including monitoring, evaluation, interpretation, management, and communication of safety information
Oversee and conduct Product Safety Committee (PSC) meetings to evaluate risk-benefit for compounds with cross-functional support
Perform medical safety review including causality assessment of safety data from pre-clinical, clinical trials, post-marketing, and literature
Provide medical expert safety review input into critical documents such as INDs, protocols, ICFs, IBs, and clinical study reports
Oversee aggregate reports and signal evaluation reports for assigned projects
Author clinical content of responses to inquiries from regulatory authorities related to safety topics
Provide leadership and support to Contract Research Organization (CRO) staff