[Hiring] Head of Clinical Operations & Biometrics @Bavarian Nordic

Role Description

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.

• 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

Qualifications

• 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%

Benefits

• Join a passionate, mission-driven global biotech committed to protecting lives
• Collaborative culture and flexible work environment
• Opportunities for ongoing professional development and growth

Company Description

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

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.

For more information, visit www.bavarian-nordic.com