Head of Clinical Operations & Biometrics

Bavarian Nordic•Durham, CA

15h•Remote

About The Position

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. 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
Demonstrated success collaborating with regulatory authorities
Strong understanding of ICH-GCP
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%

Nice To Haves

vaccine or biologics experience highly preferred
Knowledge of CDISC standards, and statistical methodologies is a plus

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