Avp, Head of Infectious Disease & Vaccines Clinical Science

Merck Merck · Pharma · NJ

The Associate Vice President (AVP), Head of Infectious Disease & Vaccines Clinical Science, is the global functional leader for the Infectious Disease & Vaccines (ID/V) Clinical Scientist (CS) organization within Infectious Disease & Vaccines Clinical Development. This role is accountable for setting scientific standards, operating model, and talent strategy for Clinical Scientists supporting our company's late stage Infectious Disease & Vaccines portfolio. The 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 Infectious Disease & Vaccines portfolio.

What you'd actually do

  1. Serves as the global head of the Infectious Disease & Vaccines Clinical Scientist function, with accountability for role clarity, scientific quality, and consistent execution across all Infectious Disease & Vaccines programs.
  2. Define and maintain clear role delineation between Clinical Scientists and Clinical Directors, aligned with our company's Clinical Development operating model.
  3. Establish expectations for scientific rigor, judgment, and decision making appropriate to phase, modality, and risk.
  4. Continually optimize organizational design, role clarity, and resourcing for Clinical Scientists aligned with portfolio priorities.
  5. Own the clinical scientist framework for Infectious Disease & Vaccines studies, including:
  6. Ensure consistency and quality of CS contributions to:
  7. Provide senior scientific input into data interpretation for clinical outcomes, safety signal evaluation, and benefit risk assessments, particularly for complex or high risk programs.
  8. Act as a senior scientific partner to Therapeutic Area Heads and Clinical Development leadership across Infectious Disease & Vaccines.
  9. Represent the Clinical Scientist function in governance forums, review committees, and inspection readiness activities, as appropriate.
  10. Partner closely with Clinical Trial Operations teams ensuring seamless work between clinical and operations.
  11. Partner closely with Regulatory, Safety, Biostatistics, and Translational Medicine to ensure integrated development strategies.
  12. Provide vision, direction, and sponsorship for the Infectious Disease & Vaccines Clinical Scientist organization.
  13. Ensure robust performance management, coaching, and career development processes are implemented by CS people leaders.
  14. Build a strong pipeline of Infectious Disease & Vaccines scientific talent with depth in disease biology, modality expertise, and clinical judgment.
  15. Foster a culture of scientific rigor, accountability, and patient focused development.
  16. Ensure Clinical Scientist processes support inspection readiness, audit outcomes, and data integrity.
  17. Drive continuous improvement informed by inspections, internal learnings, and external benchmarking.
  18. Ensure clear escalation pathways for complex scientific and safety issues.

Skills

Required

  • Postgraduate degree (MS, MA, MPH, etc.)
  • >10 years experience in Infectious Disease & Vaccines clinical development
  • Expertise with 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

Nice to have

  • Doctorate degree (PhD, PharmD, MD etc.)
  • Concentration in Infectious Disease, Vaccines, or a closely related biomedical discipline
  • Experience in building an organization
  • Experience leading CS within a clinical team organization
  • 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 company's values
  • Expert in teaching /coaching teams and individual

What the JD emphasized

  • global functional leader
  • late stage Infectious Disease & Vaccines portfolio
  • scientific standards
  • operating model
  • talent strategy
  • consistent, high quality scientific and technical oversight
  • registration and lifecycle management
  • horizontal leadership and governance
  • role clarity
  • scientific quality
  • consistent execution
  • role delineation
  • scientific rigor
  • judgment
  • decision making
  • organizational design
  • resourcing
  • portfolio priorities
  • clinical scientist framework
  • optimization of organizational design and resources
  • ownership and optimization of key processes
  • talent and succession management
  • consistency and quality of CS contributions
  • protocols and amendments
  • investigator brochures
  • medical monitoring and safety plans
  • regulatory and scientific documents
  • INDs
  • briefing packages
  • responses
  • senior scientific input
  • data interpretation
  • clinical outcomes
  • safety signal evaluation
  • benefit risk assessments
  • complex or high risk programs
  • senior scientific partner
  • governance forums
  • review committees
  • inspection readiness activities
  • clinical trial operations teams
  • integrated development strategies
  • vision
  • direction
  • sponsorship
  • performance management
  • coaching
  • career development processes
  • strong pipeline of Infectious Disease & Vaccines scientific talent
  • depth in disease biology
  • modality expertise
  • clinical judgment
  • culture of scientific rigor
  • accountability
  • patient focused development
  • inspection readiness
  • audit outcomes
  • data integrity
  • continuous improvement
  • internal learnings
  • external benchmarking
  • clear escalation pathways
  • complex scientific and safety issues
  • Senior Vice President Area Head Infectious Disease & Vaccines Clinical Development leadership
  • global Infectious Disease & Vaccines Clinical Scientist organization
  • multiple therapeutic areas and modalities of therapeutics
  • Therapeutic Area Heads
  • Product development team leads and teams
  • Heads of Clinical Science in other Areas
  • Global regulatory and safety partners
  • Global clinical trial operations teams
  • study managers
  • Finance
  • alliance management
  • compliance
  • legal
  • critical functions
  • Postgraduate degree
  • Doctorate degree
  • Concentration in Infectious Disease, Vaccines, or a closely related biomedical discipline
  • Significant experience (>10 years)
  • Infectious Disease & Vaccines clinical development
  • global pharmaceutical or biotech organization
  • Expertise with medical monitoring
  • Demonstrated leadership of clinical science teams
  • matrixed, portfolio-based environment
  • Experience working with multiple asset modalities
  • Deep understanding of trial design
  • regulatory expectations
  • medical oversight across development phases
  • particular focus for phase 3 studies
  • Experience supporting regulatory interactions
  • inspections
  • high stakes development decisions
  • US and global filing experience
  • Experience upleveling skills
  • talent assessment
  • organizational growth
  • Experience in building an organization
  • Experience leading CS within a clinical team organization
  • Ability to operate effectively at both strategic and executional levels
  • Strong influence skills without direct asset ownership
  • Commitment to patient focused development
  • scientific excellence
  • company's values
  • Expert in teaching /coaching teams and individual