Head of Clinical Operations & Biometrics

Protecting our tomorrowAbout Bavarian NordicAt 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 OverviewThe 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 trialsBuild and lead a high-performing cross-functional organization covering Clinical Operations, Biometrics, Medical Writing and Vendor/CRO OversightContribute to corporate development strategies and clinical trial design decisionsEnsure ICH-GCP compliance, and audit/inspection readinessEnsure clinical trials meet targets for timeline, budget, quality, and enrolmentOwn functional and study budgets, forecasting, and resource planningOversee and set up governance for CRO partnershipsEnsure robust data capture strategies, database design, cleaning processes, and database lock in alignment with study timelinesOversee development, validation, and documentation of data standards (e.g., CDISC).Oversee statistical design of trials, statistical analysis plans (SAPs), endpoint justification, and modellingEnsure 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 excellenceQualifications 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 positionProven leadership of Clinical Operations and Biometrics functionsExperience managing global Phase I–III trials; vaccine or biologics experience highly preferredDemonstrated success collaborating with regulatory authoritiesStrong understanding of ICH-GCP. Knowledge of CDISC standards, and statistical methodologies is a plusStrategic thinking with hands-on operational mindsetAbility to influence in matrix environments and manage external partnersHigh adaptability and comfort working in fast-paced biotechnology setting with multiple parallel prioritiesStrong financial acumen with experience overseeing department and study budgetsAbility to travel globally up to 30%Why Join UsJoin 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 PreferredDepartment: Research & Development Reports To: Senior Vice President, Research & DevelopmentSalary Range: $300k - $355kEqual Opportunity EmployerBavarian 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#LI-MA1

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