Sr. Medical Director, Drug Safety and Pharmacovigilance
Legend Biotech
August 07, 2026
On-site
Somerset, NJ
$285,906 - $375,253 USD yearly
Medical Affairs
Role Overview:
The Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy and medical expertise for assigned products across the drug development lifecycle. Drives proactive risk management initiatives aligned with global regulatory requirements; continuously evaluates safety data, performs signal detection and management, and ensures program consistency across studies with cross-functional teams.
Key Responsibilities:
- Lead/support pharmacovigilance strategy and activities for compliance with clinical development and commercial goals.
- Conduct signal detection (monitoring, evaluation, interpretation, management, communication of safety information).
- Lead Safety Monitoring Team (SMT) meetings; evaluate risk-benefit and escalate unresolved safety issues to senior management.
- Perform medical safety review and causality assessment of safety data from pre-clinical, clinical, post-marketing, and literature sources.
- Provide safety input to critical documents (IND/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Identify/manage Urgent Safety Measures.
- Oversee/author aggregate reports and signal evaluation reports.
- Lead clinical content for regulatory authority inquiries on safety topics.
- Lead/oversee CRO staff (vendor oversight) and manage internal safety scientist/safety operations teams.
- Support writing/development of SOPs to ensure regulatory/local compliance.
- Lead safety budget development and manage resources/expenses.
- Plan/executing external and internal stakeholder meetings.
- Build relationships with cross-functional teams and alliance partner; identify/mitigate project risks; prepare progress reports; support process improvement and training.
Requirements:
- MD/MBBS/MD-PhD (or equivalent).
- 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience.
- Strong US/EU pharmacovigilance regulatory knowledge.
- Experience with drug safety in registrational clinical studies.
- Medical/scientific competence; scientific analysis and drug development lifecycle knowledge (discovery to registration and post-marketing).
- Prior IND; NDA/BLA and regulatory interaction experience highly desirable.
- Demonstrated matrix leadership; prior managerial experience (coach/mentor/train; performance management).
- Excellent leadership, organization, analytics, presentation; ability to translate data into clinical strategies.
- Biotech experience preferred.
Benefits:
- Medical, dental, vision insurance; 401(k) with company match; equity/stock options (eligible roles); 8 weeks paid parental leave after 3 months; paid time off (15 vacation, 5 personal, 5 sick), 11 U.S. national holidays, 3 floating holidays; flexible spending/HSAs; life/AD&D; short-/long-term disability; legal assistance; supplemental insurance (e.g., pet, critical illness, accident, hospital indemnity); commuter benefits; family planning/care resources; well-being initiatives; peer-to-peer recognition.
Compensation:
- Anticipated base pay range: $285,906–$375,253 USD.
The Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy and medical expertise for assigned products across the drug development lifecycle. Drives proactive risk management initiatives aligned with global regulatory requirements; continuously evaluates safety data, performs signal detection and management, and ensures program consistency across studies with cross-functional teams.
Key Responsibilities:
- Lead/support pharmacovigilance strategy and activities for compliance with clinical development and commercial goals.
- Conduct signal detection (monitoring, evaluation, interpretation, management, communication of safety information).
- Lead Safety Monitoring Team (SMT) meetings; evaluate risk-benefit and escalate unresolved safety issues to senior management.
- Perform medical safety review and causality assessment of safety data from pre-clinical, clinical, post-marketing, and literature sources.
- Provide safety input to critical documents (IND/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Identify/manage Urgent Safety Measures.
- Oversee/author aggregate reports and signal evaluation reports.
- Lead clinical content for regulatory authority inquiries on safety topics.
- Lead/oversee CRO staff (vendor oversight) and manage internal safety scientist/safety operations teams.
- Support writing/development of SOPs to ensure regulatory/local compliance.
- Lead safety budget development and manage resources/expenses.
- Plan/executing external and internal stakeholder meetings.
- Build relationships with cross-functional teams and alliance partner; identify/mitigate project risks; prepare progress reports; support process improvement and training.
Requirements:
- MD/MBBS/MD-PhD (or equivalent).
- 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience.
- Strong US/EU pharmacovigilance regulatory knowledge.
- Experience with drug safety in registrational clinical studies.
- Medical/scientific competence; scientific analysis and drug development lifecycle knowledge (discovery to registration and post-marketing).
- Prior IND; NDA/BLA and regulatory interaction experience highly desirable.
- Demonstrated matrix leadership; prior managerial experience (coach/mentor/train; performance management).
- Excellent leadership, organization, analytics, presentation; ability to translate data into clinical strategies.
- Biotech experience preferred.
Benefits:
- Medical, dental, vision insurance; 401(k) with company match; equity/stock options (eligible roles); 8 weeks paid parental leave after 3 months; paid time off (15 vacation, 5 personal, 5 sick), 11 U.S. national holidays, 3 floating holidays; flexible spending/HSAs; life/AD&D; short-/long-term disability; legal assistance; supplemental insurance (e.g., pet, critical illness, accident, hospital indemnity); commuter benefits; family planning/care resources; well-being initiatives; peer-to-peer recognition.
Compensation:
- Anticipated base pay range: $285,906–$375,253 USD.