The Associate Vice President, Therapeutic Area Head (TAH) is a senior physician leader responsible for strategic oversight of clinical safety assessment and risk management across assigned therapeutic area(s).
Responsibilities:
- Provide strategic leadership and oversight for clinical safety assessment and risk management for investigational and marketed products.
- Direct and oversee Safety Physicians and Medical Associates for safety surveillance, signal detection, benefit-risk assessment, and risk management.
- Guide risk management strategy and transparent safety communication plans.
- Serve on safety governance/oversight committees; lead assessment of emerging safety signals and direct actions.
- Serve as Physician Management Reviewer for post-approval safety signal evaluations.
- Establish relationships with global health authorities; represent the company in regulatory interactions.
- Maintain oversight of safety issues, risk communications, and ongoing benefit-risk assessments.
- Partner on global pharmacovigilance systems, policies, quality standards, and SOPs; support inspection readiness.
- Partner cross-functionally to ensure integrated safety strategies and informed decision-making.
- Lead, develop, and mentor Safety Physicians; drive scientific rigor, accountability, and patient-focused decisions.
Education:
- M.D. or equivalent medical degree (Board Certification preferred).
Required Qualifications/Experience:
- 3+ years clinical experience post-training; 5+ years in Clinical Safety/Pharmacovigilance (or related); 9+ years pharma/healthcare.
- Experience people-managing teams; drug development (clinical and/or regulatory).
- Expertise in pharmacovigilance, clinical safety, and benefit-risk; strong global regulatory knowledge; cross-matrix influence.
Preferred:
- Safety strategy leadership across therapeutic areas/global portfolios (Oncology preferred); success with complex regulatory safety interactions; leadership in global PV/governance.
Required Skills:
- Pharmacovigilance, benefit-risk assessment, risk management, signal detection, safety governance, regulatory affairs, medical review, leadership, people management, stakeholder/executive communication, quality management systems.
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Deadline stated on posting.
Benefits/Compensation (as stated):
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
- Salary range: $378,100.00β$595,100.00.