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- Tasks: Lead global clinical trials and ensure high-quality execution in a dynamic biotech environment.
- Company: Join Bavarian Nordic, a leader in innovative vaccines dedicated to global health.
- Benefits: Enjoy a competitive salary, flexible work options, and opportunities for professional growth.
- Why this job: Make a real impact on global health by advancing life-saving vaccine development.
- Qualifications: Advanced degree and extensive experience in clinical development and leadership required.
- Other info: Collaborative culture with a mission-driven team focused on protecting lives.
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.
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.
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.
Head of Clinical Operations & Biometrics employer: Bavarian Nordic Group
Contact Detail:
Bavarian Nordic Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Clinical Operations & Biometrics
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharmaceutical industries. Attend relevant events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Bavarian Nordic’s mission and values. Understand their clinical operations and how they align with your experience. Tailor your responses to show how you can contribute to their goal of advancing global health through innovative vaccines.
✨Tip Number 3
Practice your pitch! Be ready to explain your leadership style and how you've successfully managed clinical trials in the past. Use specific examples that highlight your strategic thinking and operational mindset, especially in fast-paced environments.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Bavarian Nordic. Let’s protect lives together!
We think you need these skills to ace Head of Clinical Operations & Biometrics
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Head of Clinical Operations & Biometrics role. Highlight your relevant experience in clinical development and leadership, and don’t forget to mention any specific projects that align with our mission at Bavarian Nordic.
Showcase Your Achievements: When detailing your experience, focus on quantifiable achievements. Did you lead a successful clinical trial? Share the results! We love seeing how you've made an impact in your previous roles, especially in the biotech or pharmaceutical industries.
Keep It Professional Yet Personal: While we want to see your professional side, don’t hesitate to let your personality shine through. A bit of authenticity can go a long way in making your application stand out. Remember, we’re looking for someone who fits into our collaborative culture!
Apply Through Our Website: We encourage you to submit your application directly through our website. This ensures it gets to the right people quickly and helps us keep track of all applications efficiently. Plus, it’s super easy to do!
How to prepare for a job interview at Bavarian Nordic Group
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical operations and biometrics. Understand the key responsibilities of the role, especially around ICH-GCP compliance and statistical methodologies. Being able to discuss these topics confidently will show that you're serious about the position.
✨Showcase Your Leadership Skills
As a Head of Clinical Operations & Biometrics, you'll need to demonstrate your leadership experience. Prepare examples of how you've built and led high-performing teams in the past. Highlight any specific achievements in managing global trials or working with CROs that showcase your ability to lead effectively.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and strategic thinking. Think about challenges you've faced in previous roles and how you overcame them. This is your chance to show how you can adapt and thrive in a fast-paced environment.
✨Align with Their Mission
Bavarian Nordic is all about protecting lives through innovative vaccines. Make sure you express your passion for global health and how your values align with their mission. This connection can set you apart from other candidates who may not have the same level of commitment.