Head of Clinical Operations & Biometrics

Bavarian Nordic • Durham, NC

2d • Remote

About The Position

Protecting our tomorrow 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 The Head of Clinical Operations & Biometrics is accountable for planning, executing, and delivering Bavarian Nordic’s global clinical trial portfolio. This role oversees Clinical Operations, Data Management, Biostatistics, Medical Writing and Statistical Programming, ensuring high-quality, compliant, and efficient clinical development execution.

Requirements

• Advanced degree in Life Sciences, Biostatistics, Public Health, Medicine, or related field (PhD, MSc, MPH, MD preferred)
• 15+ years in clinical development within biotechnology or pharmaceutical industries. At least 5 years in a leadership position
• Proven leadership of Clinical Operations and Biometrics functions
• Experience managing global Phase I–III trials; vaccine or biologics experience highly preferred
• Demonstrated success collaborating with regulatory authorities
• Strong understanding of ICH-GCP. Knowledge of CDISC standards, and statistical methodologies is a plus
• Strategic thinking with hands-on operational mindset
• Ability to influence in matrix environments and manage external partners
• High adaptability and comfort working in fast-paced biotechnology setting with multiple parallel priorities
• Strong financial acumen with experience overseeing department and study budgets
• Ability to travel globally up to 30%

Responsibilities

• Develop and execute the overall clinical operations strategy across Phase I–IV trials
• Build and lead a high-performing cross-functional organization covering Clinical Operations, Biometrics, Medical Writing and Vendor/CRO Oversight
• Contribute to corporate development strategies and clinical trial design decisions
• Ensure ICH-GCP compliance, and audit/inspection readiness
• Ensure clinical trials meet targets for timeline, budget, quality, and enrolment
• Own functional and study budgets, forecasting, and resource planning
• Oversee and set up governance for CRO partnerships
• Ensure robust data capture strategies, database design, cleaning processes, and database lock in alignment with study timelines
• Oversee development, validation, and documentation of data standards (e.g., CDISC).
• Oversee statistical design of trials, statistical analysis plans (SAPs), endpoint justification, and modelling
• Ensure regulatory-grade statistical outputs and programming deliverables (TFLs, CSR outputs, submission datasets)
• Build capabilities, develop talent, and mentor clinical operations and biometrics leaders and foster a culture of quality, accountability, and operational excellence

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees