Head of Clinical Operations & Biometrics

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.

Key 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

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%

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.

Location: US Remote; East Coast Preferred

Department: Research & Development 

Reports To: Senior Vice President, Research & Development

Salary Range: $300k - $355k

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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