AVP, Head of Infectious Disease & Vaccines Clinical Science
Merck
12 days ago
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Primary Responsibilities
- Serve as global head of the Infectious Disease & Vaccines Clinical Scientist function; ensure role clarity, scientific quality, and consistent execution across ID/V programs.
- Define delineation between Clinical Scientists and Clinical Directors; set expectations for scientific rigor/judgment by phase/modality/risk.
- Optimize org design, role clarity, and resourcing for Clinical Scientists aligned to portfolio priorities.
- Own CS framework: organizational design/resources; processes, talent and succession management.
- Ensure CS quality for protocols/amendments, investigator brochures, medical monitoring & safety plans, and regulatory/scientific documents; provide input for data interpretation, safety signal evaluation, and benefit-risk assessments.
- Partner with Therapeutic Area Heads and Clinical Development leadership; represent function in governance/inspection readiness.
- Partner with Clinical Trial Operations and with Regulatory, Safety, Biostatistics, and Translational Medicine for integrated strategies.
- Provide vision/sponsorship; ensure performance management, coaching, and career development; build talent pipeline and foster patient-focused scientific rigor.
- Ensure inspection readiness, audit outcomes, and data integrity; drive continuous improvement and escalation paths.
Qualifications
- Minimum: Postgraduate degree (MS/MA/MPH etc.); Doctorate (PhD/PharmD/MD) preferred; focus in Infectious Disease/Vaccines or related biomedical discipline preferred.
- >10 years in ID/V clinical development (pharma/biotech); medical monitoring expertise; leadership in matrix portfolio environments; experience across multiple modalities; deep trial design/regulatory/medical oversight (esp. Phase 3); regulatory/inspection experience; US and global filing experience; talent assessment/organizational growth; CS leadership in clinical teams preferred.
Skills (required)
- Biostatistics, Client Management, Clinical Judgment, Clinical Research Methods, Conflict Resolution, Detail-Oriented, Innovation, Multiple Therapeutic Areas, Negotiation, New Technology Integration, People Leadership, Pharmacovigilance, Protocol Development, Strategic Planning, Visionary Leadership.
Benefits
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline stated on posting.
- Serve as global head of the Infectious Disease & Vaccines Clinical Scientist function; ensure role clarity, scientific quality, and consistent execution across ID/V programs.
- Define delineation between Clinical Scientists and Clinical Directors; set expectations for scientific rigor/judgment by phase/modality/risk.
- Optimize org design, role clarity, and resourcing for Clinical Scientists aligned to portfolio priorities.
- Own CS framework: organizational design/resources; processes, talent and succession management.
- Ensure CS quality for protocols/amendments, investigator brochures, medical monitoring & safety plans, and regulatory/scientific documents; provide input for data interpretation, safety signal evaluation, and benefit-risk assessments.
- Partner with Therapeutic Area Heads and Clinical Development leadership; represent function in governance/inspection readiness.
- Partner with Clinical Trial Operations and with Regulatory, Safety, Biostatistics, and Translational Medicine for integrated strategies.
- Provide vision/sponsorship; ensure performance management, coaching, and career development; build talent pipeline and foster patient-focused scientific rigor.
- Ensure inspection readiness, audit outcomes, and data integrity; drive continuous improvement and escalation paths.
Qualifications
- Minimum: Postgraduate degree (MS/MA/MPH etc.); Doctorate (PhD/PharmD/MD) preferred; focus in Infectious Disease/Vaccines or related biomedical discipline preferred.
- >10 years in ID/V clinical development (pharma/biotech); medical monitoring expertise; leadership in matrix portfolio environments; experience across multiple modalities; deep trial design/regulatory/medical oversight (esp. Phase 3); regulatory/inspection experience; US and global filing experience; talent assessment/organizational growth; CS leadership in clinical teams preferred.
Skills (required)
- Biostatistics, Client Management, Clinical Judgment, Clinical Research Methods, Conflict Resolution, Detail-Oriented, Innovation, Multiple Therapeutic Areas, Negotiation, New Technology Integration, People Leadership, Pharmacovigilance, Protocol Development, Strategic Planning, Visionary Leadership.
Benefits
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline stated on posting.