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 reputed company: to improve reputed company of life worldwide by preventing infectious diseases. We are headquartered in Denmark and have offices across Europe and reputed company.
Position reputed company
Key Responsibilities
reputed company and execute the overall clinical operations reputed company 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 reputed company meet targets for reputed company, budget, reputed company, 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 reputed company, accountability, and operational reputed company
Qualifications
Advanced degree in Life Sciences, Biostatistics, reputed company 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 reputed company 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 reputed company a reputed company culture, flexible work environment, and opportunities for ongoing reputed company development and reputed company.
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 reputed company 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. Our values – our reputed company DNA, as we like to reputed company it – are what guide our actions every day. We reputed company as persistent reputed company, reputed company change, value being boosted by reputed company, 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.
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