Head of Medical Affairs & GCSP (Global Clinical Safety & Pharmacovigilance)

Bavarian Nordic • Durham, CA

4d • Remote

About The Position

We’re looking for an experienced Head of Medical Affairs & GCSP (Global Clinical Safety and Pharmacovigilance) providing medical leadership across GCSP, Epidemiology, Medical Affairs, and Medical & Process Compliance. You will guide patient safety and benefit–risk, shape evidence generation and medical governance, and partner closely with Regulatory, Clinical Development, Quality, CMC/Manufacturing, Commercial, and Market Access to ensure scientific rigor and aligned execution across the product lifecycle. The position reports to the SVP of R&D and should be based on the East Coast of the United States - global travel up to ~30% should be expected.

Requirements

• Advanced degree is required, and an MD qualification is preferred for this role
• Expertise in medical affairs, clinical safety, and global pharmacovigilance, with a strong foundation in immunology, epidemiology, and vaccine safety
• 10+ years’ experience in a similar role
• Strategic mindset and operational rigor to ensure patient safety and scientific excellence across the product lifecycle
• 10+ years’ experience from a leadership role with both direct and indirect reports
• Exceptional communicator who can translate complex medical and regulatory topics into clear, actionable guidance for both scientific and non-scientific stakeholders
• As a trusted advisor to senior leadership, you provide confident counsel on medical strategy, compliance, and risk management
• As a leader, you’re hands-on and people-focused—ready to coach, mentor, and elevate high-performing teams across regions—while orchestrating medical governance, evidence generation, and external collaborations with precision and credibility
• Curious and data-driven; you monitor emerging trends, synthesize real-world evidence, and challenge assumptions to inform better decisions
• Most importantly, you thrive in change; your judgment, integrity, and resilience help safeguard patient safety and support our transition from development to full commercialization in a fast-moving, life-science environment

Responsibilities

• Lead and develop high-performing GCSP, Epidemiology, Medical Affairs, and Medical & Process Compliance teams, including people leadership, budgets, and talent development
• Have oversight of the GCSP team and QPPV office
• Set and execute global Medical Affairs strategy aligned to development milestones, regulatory interactions, and commercialization plans; ensure medical accuracy and balance across all external scientific content
• Establish and scale regional medical networks to support local commercial teams, capture insights, and localize global strategies
• Own medical information capabilities and responses to unsolicited medical inquiries
• Drive late-stage and post-approval evidence generation, including RWE, observational, and epidemiological studies
• Institute robust medical governance appropriate for company growth; chair and/or contribute to internal medical governance committees
• Partner deeply with Clinical Development to inform future trials and label expansions; collaborate across Regulatory, Manufacturing/CMC, Quality, Commercial, and Market Access
• Build strategic external relationships with key opinion leaders and public-health stakeholders

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees