AVP, Head of General & Specialty Medicine Clinical Science

Job Description

The Associate Vice President, Head of General & Specialty Medicine Clinical Science, is the global functional leader for the General & Specialty Medicine Clinical Scientist (CS) organization within General & Specialty Medicine Clinical Development. This role is accountable for setting scientific standards, operating model, and talent strategy for Clinical Scientists supporting our company's late stage General & Specialty Medicine portfolio across Immunology, Cardiovascular & Respiratory, Atherosclerosis & Metabolism, and Neuroscience.

The Associate Vice President (AVP) ensures that Clinical Scientists deliver consistent, high quality- scientific and technical oversight of studies and assets, partnering closely with Clinical Directors (CDs), Product Development Team Leaders, Therapeutic Area Heads, Global Clinical Trials operations teams as well as other cross functional partners to advance programs from First-In-Human-through registration and lifecycle management.

This role is not asset specific; rather, it provides horizontal leadership and governance of clinical scientists across the General & Specialty Medicine portfolio.

Primary Responsibilities:

Functional & Strategic Leadership:

• Serves as the global head of the General & Specialty Medicine Clinical Scientist function, with accountability for role clarity, scientific quality, and consistent execution across all General & Specialty Medicine programs.
• Define and maintain clear role delineation between Clinical Scientists and Clinical Directors, aligned with our company's Clinical Development operating model.
• Establish expectations for scientific rigor, judgment, and decision making appropriate to- phase, modality, and risk.
• Continually optimize organizational design, role clarity, and resourcing for Clinical Scientists aligned with portfolio priorities.

Clinical Science Standards & Quality:

• Own the clinical scientist framework for General & Specialty Medicine studies, including:
  
  • Optimization of organizational design and resources
  • Ownership and optimization of key processes, talent and succession management

• Ensure consistency and quality of CS contributions to:
  
  • Protocols and amendments
  • Investigator Brochures
  • Medical monitoring and safety plans
  • Regulatory and scientific documents (e.g., INDs, briefing packages, responses)
• Provide senior scientific input into data interpretation for clinical outcomes, safety signal evaluation, and benefit risk assessments, particularly for complex or high- risk- programs.

Matrix Partnership & Governance:

• Act as a senior scientific partner to Therapeutic Area Heads and Clinical Development leadership across General & Specialty Medicine.
• Represent the Clinical Scientist function in governance forums, review committees, and inspection readiness activities, as appropriate.
• Partner closely with Clinical Trial Operations teams ensuring seamless work between clinical and operations.
• Partner closely with Regulatory, Safety, Biostatistics, and Translational Medicine to ensure integrated development strategies.

Talent Development & Capability Building:

• Provide vision, direction, and sponsorship for the General & Specialty Medicine Clinical Scientist organization.
• Ensure robust performance management, coaching, and career development processes are implemented by CS people leaders.
• Build a strong pipeline of General & Specialty Medicine scientific talent with depth in disease biology, modality expertise, and clinical judgment.
• Foster a culture of scientific rigor, accountability, and patient focused- development.

Operational Excellence & Inspection Readiness:

• Ensure Clinical Scientist processes support inspection readiness, audit outcomes, and data integrity.
• Drive continuous improvement informed by inspections, internal learnings, and external benchmarking.
• Ensure clear escalation pathways for complex scientific and safety issues.

Scope & Reporting:

• Reports into the Senior Vice President Area Head General & Specialty Medicine Clinical Development leadership
• Leads a global General & Specialty Medicine Clinical Scientist organization supporting multiple therapeutic areas and modalities of therapeutics.
• Interfaces routinely with:
  
  • Therapeutic Area Heads
  • Product development team leads and teams
  • Heads of Clinical Science in other Areas (Oncology, ID/Vaccines)
  • Global regulatory and safety partners
  • Global clinical trial operations teams including study managers
  • Finance, alliance management, compliance, legal and other critical functions

Education & Training:

• Minimum requirement: PhD, PharmD, MD or DO strongly preferred
• 10-15 years of relevant experience in any areas covered by General & Specialty Medicine (Immunology, Cardiometabolic, Respiratory, Neuroscience, Metabolism)

Required Experience and Skills:

• Significant experience (>10 years) in General & Specialty Medicine clinical development within a global pharmaceutical or biotech organization.
• Expertise with medical monitoring including medical monitoring.
• Demonstrated leadership of clinical science teams in a matrixed, portfolio-based environment.
• Experience working with multiple asset modalities.
• Deep understanding of trial design, regulatory expectations, and medical oversight across development phases, with particular focus for phase 3 studies.
• Experience supporting regulatory interactions, inspections, and high stakes development decisions.
• US and global filing experience.
• Experience upleveling skills; talent assessment and organizational growth. Experience in building an organization preferred.
• Experience leading CS within a clinical team organization preferred.

Leadership & Competencies:

• Ability to operate effectively at both strategic and executional levels.
• Strong influence skills without direct asset ownership.
• Commitment to patient-focused development, scientific excellence, and our company's values.
• Expert in teaching/coaching teams and individuals.
• Proven ability to lead cross-functional strategic and process improvement initiatives.
• Business-savvy, results-oriented, and able to balance rigor, speed, and risk.
• Strong communication, influence, and people-development skills.

Required Skills:
Biostatistics, Biostatistics, Client Management, Clinical Development, Clinical Judgment, Clinical Research Methods, Clinical Sciences, Conflict Resolution, Detail-Oriented, Immunoassays, Immunology, Immunotherapy, Innovation, Multiple Therapeutic Areas, Negotiation, New Technology Integration, Oncology, Operating Models, Operational Excellence, Organizational Performance Management, Pathophysiology, People Leadership, Pharmacovigilance, Physiology, Protocol Development {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$342,800.00 - $539,600.00

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 .

You can apply for this role through (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

Search Firm Representatives Please Read Carefully-
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:
05/21/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R397063