Sr. Medical Director, Drug Safety and Pharmacovigilance
Legend Biotech
June 25, 2026
Remote friendly (Somerset, NJ)
United States
$285,906 - $375,253 USD yearly
Medical Affairs
Role Overview:
Sr. Medical Director, Drug Safety & Pharmacovigilance (Clinical Development Team) in Somerset, NJ.
Key Responsibilities:
- Develop and lead pharmacovigilance strategy/activities to meet clinical development and commercial goals.
- Conduct signal detection (monitoring, evaluation, interpretation, management, and communication of safety information).
- Run Safety Monitoring Team (SMT) meetings; evaluate risk-benefit; escalate unresolved issues to senior leadership.
- Perform medical safety review and causality assessments across preclinical, clinical, post-marketing, and literature sources.
- Provide medical expert safety input into critical documents (IND/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Identify and manage Urgent Safety Measures.
- Oversee/author aggregate reports and signal evaluation reports.
- Lead clinical safety content for regulatory authority inquiries.
- Provide CRO leadership/vendor oversight; ensure delivery of services.
- Oversee internal safety scientists/safety operations team.
- Support SOP writing/development for compliance.
- Manage drug safety budget and resources.
- Plan/execution of external and internal stakeholder meetings (e.g., Governance, DMCs, SSC, Regulatory).
- Build relationships with cross-functional teams and alliance partner; identify risks and mitigate delays; report progress.
- Support process improvement and functional training.
Requirements:
- MD/MBBS/MD-PhD or equivalent.
- 5+ years in drug safety/pharmacovigilance.
- Strong US/EU pharmacovigilance regulatory knowledge.
- Experience in registrational clinical studies drug safety.
- Strong scientific analysis/reasoning; knowledge from discovery through registration and post-marketing surveillance.
- Prior IND; NDA/BLA and other regulatory interaction experience highly desirable.
- Proven leadership in matrix; experience managing/coaching/mentoring teams.
- Excellent leadership, organizational, presentation skills; translate data into clinical strategies.
- Biotech experience preferred but not required.
Sr. Medical Director, Drug Safety & Pharmacovigilance (Clinical Development Team) in Somerset, NJ.
Key Responsibilities:
- Develop and lead pharmacovigilance strategy/activities to meet clinical development and commercial goals.
- Conduct signal detection (monitoring, evaluation, interpretation, management, and communication of safety information).
- Run Safety Monitoring Team (SMT) meetings; evaluate risk-benefit; escalate unresolved issues to senior leadership.
- Perform medical safety review and causality assessments across preclinical, clinical, post-marketing, and literature sources.
- Provide medical expert safety input into critical documents (IND/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Identify and manage Urgent Safety Measures.
- Oversee/author aggregate reports and signal evaluation reports.
- Lead clinical safety content for regulatory authority inquiries.
- Provide CRO leadership/vendor oversight; ensure delivery of services.
- Oversee internal safety scientists/safety operations team.
- Support SOP writing/development for compliance.
- Manage drug safety budget and resources.
- Plan/execution of external and internal stakeholder meetings (e.g., Governance, DMCs, SSC, Regulatory).
- Build relationships with cross-functional teams and alliance partner; identify risks and mitigate delays; report progress.
- Support process improvement and functional training.
Requirements:
- MD/MBBS/MD-PhD or equivalent.
- 5+ years in drug safety/pharmacovigilance.
- Strong US/EU pharmacovigilance regulatory knowledge.
- Experience in registrational clinical studies drug safety.
- Strong scientific analysis/reasoning; knowledge from discovery through registration and post-marketing surveillance.
- Prior IND; NDA/BLA and other regulatory interaction experience highly desirable.
- Proven leadership in matrix; experience managing/coaching/mentoring teams.
- Excellent leadership, organizational, presentation skills; translate data into clinical strategies.
- Biotech experience preferred but not required.