AVP, Therapeutic Area Head, Clinical Safety and Risk Management

MSD · United States

Job Description The Associate Vice President, Therapeutic Area Head (TAH) is a senior physician leader responsible for the strategic oversight of clinical safety assessment and risk management for a broad portfolio of investigational and marketed products across one or more therapeutic areas. Reporting to the Vice President, Clinical Safety and Risk Management (CSRM), this role provides leadership and oversight for teams of Safety Physicians who are accountable for all aspects of safety surveillance, benefit-risk evaluation, signal management, and risk mitigation throughout the product lifecycle. The role also provides strategic direction and partnership to Medical Associates operating within a matrix environment to support the execution of safety and risk management activities. As a member of the Global Clinical Safety & Pharmacovigilance (GCS&PV) Leadership Team, the TAH plays a critical role in shaping safety strategy, influencing enterprise decision-making, and ensuring the highest standards of patient safety and regulatory compliance globally. The Therapeutic Area Head partners extensively with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Epidemiology, and other key functions to support informed benefit-risk decisions and successful execution of the Company's development and commercial portfolios. Key Responsibilities: Clinical Safety and Risk Management Leadership

• Provide strategic leadership and oversight for the clinical safety assessment and risk management of investigational and marketed pharmaceutical products across assigned therapeutic area(s).
• Direct and oversee Safety Physicians and Medical Associates responsible for safety surveillance, signal detection, benefit-risk assessment, and risk management activities.
• Ensure robust understanding of product safety profiles throughout clinical development, regulatory review, and commercialization.
• Guide development and implementation of effective risk management strategies and transparent safety communication plans.

• Serve on key governance, management, oversight, and safety review committees, providing expert medical and pharmacovigilance leadership.
• Lead assessment of emerging safety signals and direct appropriate actions to address potential safety concerns.
• Serve as Physician Management Reviewer for post-approval safety signal evaluations.
• Establish and maintain productive relationships with global health authorities to support effective communication regarding product safety issues.
• Represent the Company in regulatory interactions and contribute to discussions related to evolving pharmacovigilance and risk management requirements.

• Maintain oversight of safety issues, risk communications, and ongoing benefit-risk assessments for products with approved market authorizations.
• Partner with GCS&PV leadership to establish, maintain, and continuously improve global pharmacovigilance systems, processes, and quality standards.
• Provide leadership in the development and maintenance of pharmacovigilance policies, quality systems, and standard operating procedures.
• Collaborate with Compliance leadership to ensure robust pharmacovigilance quality management programs and inspection readiness.

• Partner with Clinical Development, Regulatory Affairs, Biostatistics, Epidemiology, and other stakeholders to ensure integrated safety strategies and informed decision-making.
• Represent CSRM and GCS&PV on enterprise initiatives and cross-functional leadership teams.
• Serve as a scientific and medical subject matter expert on national and international pharmacovigilance, drug safety, vaccine safety, and risk management committees.
• Engage with industry thought leaders and regulatory agencies to shape industry best practices and emerging safety guidance.

• Lead, develop, and mentor a high-performing organization of Safety Physicians.
• Build a culture of scientific rigor, collaboration, accountability, and patient-focused decision-making.
• Provide oversight of departmental resources, including budget planning, expense management, and compliance with financial stewardship requirements.
• Drive organizational effectiveness through talent development, succession planning, and continuous improvement initiatives.

• M.D. or equivalent medical degree
• Board Certification preferred

• Minimum of 3 years of clinical experience following postgraduate medical training or equivalent clinical practice experience.
• Minimum of 5 years of experience in Clinical Safety, Pharmacovigilance, or a related field.
• Minimum of 9 years of pharmaceutical industry experience or experience in a related healthcare discipline.
• Previous experience leading and developing teams in a people management capacity.
• Experience supporting drug development programs, including clinical development and/or regulatory activities.
• Demonstrated expertise in pharmacovigilance, clinical safety assessment, and benefit-risk evaluation.
• Strong knowledge of global pharmacovigilance regulations, regulatory expectations, and medical practices.
• Broad understanding of pharmaceutical research, development, and commercialization processes.
• Proven ability to influence strategic decisions and collaborate effectively across complex, matrixed organizations.
• Excellent leadership, communication, stakeholder management, and executive presentation skills.

• Experience leading safety strategy across multiple therapeutic areas and global product portfolios. Oncology experience is preferred.
• Demonstrated success interacting with regulatory authorities on complex safety and risk management matters.
• Leadership experience within global pharmacovigilance organizations and governance structures.
• Strong understanding of evolving global benefit-risk assessment methodologies and risk management practices.
• Experience representing organizations in industry forums, professional societies, or international safety committees.