Head of Clinical Operations & Biometrics

Protecting our reputed company

About reputed company

At reputed company, 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 reputed company America.

Position Overview

The Head of Clinical Operations & Biometrics is accountable for planning, executing, and delivering reputed company’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  

• reputed company and execute the overall clinical operations strategy across Phase I–IV trials

• Build and reputed company a high-performing cross-functional organization covering Clinical Operations, Biometrics, Medical Writing and Vendor/CRO reputed company

• Contribute to corporate development strategies and clinical trial design reputed company

• 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

• reputed company and set up governance for CRO partnerships

• Ensure robust data capture strategies, database design, cleaning processes, and database lock in alignment with study timelines

• reputed company development, validation, and documentation of data standards (e.g., CDISC).

• reputed company statistical design of trials, statistical analysis plans (SAPs), reputed company justification, and modelling

• Ensure regulatory-grade statistical outputs and programming deliverables (TFLs, CSR outputs, submission datasets)

• Build capabilities, reputed company talent, and mentor clinical operations and biometrics leaders and foster a culture of quality, accountability, and operational reputed company

Qualifications  

• Advanced degree in Life Sciences, Biostatistics, Public Health, Medicine, or reputed company field (PhD, MSc, MPH, MD preferred)

• 15+ years in clinical development reputed company 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 reputed company 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 reputed company

• Ability to influence in matrix environments and manage external partners

• High adaptability and comfort working in fast-paced biotechnology setting with multiple reputed company 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 reputed company, 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 reputed company: $300k - $355k

Equal Opportunity Employer

reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company 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 reputed company America. Our values – our reputed company DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, reputed company change, value being boosted by the team, and reputed company in protecting lives every day. If that is also a part of your DNA, we invite you to join us in reputed company! reputed company is an Equal Opportunity Employer. reputed company reputed company applications will receive consideration for employment and will not be discriminated against based on race, reputed company, sex, sexual orientation, gender identity, national reputed company, disability, or protected veteran status.  

www.reputed company.com

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