Head Of Medical Affairs & Gcsp (Global Clinical Safety & Pharmacovigilance)
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Overview
Job Description
Protecting our tomorrow
Job Title: Head of Medical Affairs & GCSP (Global Clinical Safety & Pharmacovigilance)
Location: Remote - US East Coast
Department: Research & Development
Reports To: Senior VP of R&D
Salary Range: $325k - $415k
About Bavarian Nordic
At Bavarian Nordic, we are dedicated to protecting lives and advancing global health through innovative vaccines. As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, chikungunya, cholera, and typhoid. Our mission is simple: to improve quality of life worldwide by preventing infectious diseases. We are headquartered in Denmark and have offices across Europe and North America.
Position Overview
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.
Key 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
Qualifications
- 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
Why Join Us
Join a passionate, mission-driven global biotech committed to protecting lives. At Bavarian Nordic, you'll find a collaborative culture, flexible work environment, and opportunities for ongoing professional development and growth.
Equal Opportunity Employer
Bavarian Nordic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
www.bavarian-nordic.com
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