AVP, Head of Infectious Disease & Vaccines Clinical Science
Merck
12 days ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Primary Responsibilities
- Global functional leadership for Infectious Disease & Vaccines Clinical Scientist organization; ensure role clarity, scientific quality, and consistent execution.
- Define delineation between Clinical Scientists and Clinical Directors; set expectations for scientific rigor and decision-making by phase/modality/risk.
- Optimize organizational design, role clarity, and resourcing.
- Own the clinical scientist framework: processes, talent, succession; ensure quality of CS deliverables (protocols/amendments, investigator brochures, medical monitoring/safety plans, INDs and other scientific/regulatory documents).
- Provide senior input to data interpretation, safety signal evaluation, and benefit-risk assessments (esp. complex/high-risk programs).
- Partner with Therapeutic Area Heads, Clinical Development leadership, Clinical Trial Operations, Regulatory, Safety, Biostatistics, and Translational Medicine; represent the function in governance/inspection readiness.
- Drive performance management, coaching/career development, and build a strong pipeline of scientific talent; foster rigorous, accountable, patient-focused development.
- Ensure inspection readiness, audit outcomes, data integrity, continuous improvement, and clear escalation pathways.
Qualifications
- Postgraduate degree (MS/MA/MPH etc.); PhD/MD/PharmD preferred; focus in Infectious Disease/Vaccines or related biomedical discipline preferred.
- 10+ years in Infectious Disease & Vaccines clinical development in global pharma/biotech; expertise in medical monitoring.
- Leadership in matrix/portfolio environment; experience across multiple modalities.
- Deep understanding of trial design, regulatory expectations, medical oversight (esp. Phase 3); regulatory interactions/inspections; US and global filing experience.
Skills/Competencies (required)
- Biostatistics, clinical judgment, protocol development, pharmacovigilance, strategic planning, people leadership, conflict resolution, negotiation, communication/influence.
Benefits
- Eligible for annual bonus and long-term incentive (if applicable) and comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate days).
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees); application deadline is listed on the posting.
- Global functional leadership for Infectious Disease & Vaccines Clinical Scientist organization; ensure role clarity, scientific quality, and consistent execution.
- Define delineation between Clinical Scientists and Clinical Directors; set expectations for scientific rigor and decision-making by phase/modality/risk.
- Optimize organizational design, role clarity, and resourcing.
- Own the clinical scientist framework: processes, talent, succession; ensure quality of CS deliverables (protocols/amendments, investigator brochures, medical monitoring/safety plans, INDs and other scientific/regulatory documents).
- Provide senior input to data interpretation, safety signal evaluation, and benefit-risk assessments (esp. complex/high-risk programs).
- Partner with Therapeutic Area Heads, Clinical Development leadership, Clinical Trial Operations, Regulatory, Safety, Biostatistics, and Translational Medicine; represent the function in governance/inspection readiness.
- Drive performance management, coaching/career development, and build a strong pipeline of scientific talent; foster rigorous, accountable, patient-focused development.
- Ensure inspection readiness, audit outcomes, data integrity, continuous improvement, and clear escalation pathways.
Qualifications
- Postgraduate degree (MS/MA/MPH etc.); PhD/MD/PharmD preferred; focus in Infectious Disease/Vaccines or related biomedical discipline preferred.
- 10+ years in Infectious Disease & Vaccines clinical development in global pharma/biotech; expertise in medical monitoring.
- Leadership in matrix/portfolio environment; experience across multiple modalities.
- Deep understanding of trial design, regulatory expectations, medical oversight (esp. Phase 3); regulatory interactions/inspections; US and global filing experience.
Skills/Competencies (required)
- Biostatistics, clinical judgment, protocol development, pharmacovigilance, strategic planning, people leadership, conflict resolution, negotiation, communication/influence.
Benefits
- Eligible for annual bonus and long-term incentive (if applicable) and comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate days).
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees); application deadline is listed on the posting.