AVP, Therapeutic Area Head, Clinical Safety and Risk Management
Merck
September 02, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Associate Vice President, Therapeutic Area Head (TAH)
Key Responsibilities
- Provide strategic leadership/oversight for clinical safety assessment and risk management across assigned therapeutic area(s).
- Direct Safety Physicians and Medical Associates for safety surveillance, signal detection, benefit-risk assessment, and risk mitigation.
- Ensure understanding of product safety profiles across development, regulatory review, and commercialization.
- Guide risk management strategy and transparent safety communication plans.
- Serve on safety governance/oversight committees; lead assessment of emerging safety signals and direct actions.
- Act 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 benefit-risk assessments for approved products.
- Partner to improve global pharmacovigilance systems/processes/quality standards; lead pharmacovigilance policies, quality systems, and SOPs; support inspection readiness.
- Partner cross-functionally (Clinical Development, Regulatory, Biostats, Epidemiology) to enable integrated safety strategies.
- Lead, develop, mentor Safety Physicians; drive scientific rigor, collaboration, accountability, and patient-focused decisions.
Education
- M.D. or equivalent medical degree (Board Certification preferred).
Required Experience/Skills
- 3+ years clinical experience post-training; 5+ years Clinical Safety/Pharmacovigilance (or related); 9+ years pharma/healthcare discipline.
- People management experience; drug development (clinical and/or regulatory) experience.
- Expertise in pharmacovigilance, clinical safety assessment, benefit-risk evaluation; global regulations knowledge; executive communication and stakeholder management.
Preferred Experience/Skills
- Safety strategy leadership across multiple therapeutic areas/global portfolios (oncology preferred); regulatory engagement success.
Benefits/Incentives (if applicable)
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, 401(k), paid holidays, vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Key Responsibilities
- Provide strategic leadership/oversight for clinical safety assessment and risk management across assigned therapeutic area(s).
- Direct Safety Physicians and Medical Associates for safety surveillance, signal detection, benefit-risk assessment, and risk mitigation.
- Ensure understanding of product safety profiles across development, regulatory review, and commercialization.
- Guide risk management strategy and transparent safety communication plans.
- Serve on safety governance/oversight committees; lead assessment of emerging safety signals and direct actions.
- Act 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 benefit-risk assessments for approved products.
- Partner to improve global pharmacovigilance systems/processes/quality standards; lead pharmacovigilance policies, quality systems, and SOPs; support inspection readiness.
- Partner cross-functionally (Clinical Development, Regulatory, Biostats, Epidemiology) to enable integrated safety strategies.
- Lead, develop, mentor Safety Physicians; drive scientific rigor, collaboration, accountability, and patient-focused decisions.
Education
- M.D. or equivalent medical degree (Board Certification preferred).
Required Experience/Skills
- 3+ years clinical experience post-training; 5+ years Clinical Safety/Pharmacovigilance (or related); 9+ years pharma/healthcare discipline.
- People management experience; drug development (clinical and/or regulatory) experience.
- Expertise in pharmacovigilance, clinical safety assessment, benefit-risk evaluation; global regulations knowledge; executive communication and stakeholder management.
Preferred Experience/Skills
- Safety strategy leadership across multiple therapeutic areas/global portfolios (oncology preferred); regulatory engagement success.
Benefits/Incentives (if applicable)
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, 401(k), paid holidays, vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).