AVP, Therapeutic Area Head, Clinical Safety and Risk Management

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.

Safety Governance and Regulatory Engagement

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.

Global Pharmacovigilance and Compliance

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.

Cross-Functional and External Leadership

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.

People Leadership and Organizational Impact

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.

Education Requirement:

M.D. or equivalent medical degree

Board Certification preferred

Required Experience and Skills:

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.

Preferred Experience and 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.

Required Skills:

Clinical Safety, Clinical Development, Drug Development, Drug Safety Surveillance, Pharmacovigilance, Benefit-Risk Assessment, Risk Management, Signal Detection, Safety Governance, Regulatory Affairs, Medical Review, Global Safety Compliance, Patient Safety, Leadership, People Management, Strategic Planning, Cross-Functional Leadership, Stakeholder Management, Quality Management Systems, Health Authority Interactions, Executive Communication, Pharmaceutical Industry Experience.

Required Skills:

Analytical Problem Solving, Change Management, Clinical Risk Management, Clinical Safety, Clinical Trial Oversight, Conflict Resolution, Cross-Cultural Awareness, Drug Development, Drug Safety Surveillance, Ethical Compliance, Mentoring Staff, People Leadership, Pharmaceutical Research, Pharmacovigilance, Product Safety, Results-Oriented, Risk Assessments, Risk Management, Safety Compliance, Safety Management, Safety Observations, Stakeholder Management, Strategic Planning, Succession Planning, Team Management

Preferred Skills:

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US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

$378,100.00 - $595,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:  We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:  We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R412063