Co-chairs clinical study teams and provides clinical and scientific expertise to study strategy and protocol development, ensuring efficient clinical protocols are developed through application of Enhanced Clinical Trial Design
Job Summary
Co-chairs clinical study teams and provides clinical and scientific expertise to study strategy and protocol development, ensuring efficient clinical protocols are developed through application of Enhanced Clinical Trial Design.
Accountable for the design, conduct, interpretation, and reporting of clinical studies, including risk assessment, mitigation plans, and oversight of study team activities.
Contributes to CRO/vendor selection, approves country/site/investigator selection, ensures study registration, and develops clinical/protocol training materials.
Matching Summary
Co-chairs clinical study teams and provides clinical and scientific expertise to study strategy and protocol development, ensuring efficient clinical protocols are developed through application of Enhanced Clinical Trial Design.
Skills & Requirements
Must-have
Clinical study design and conduct
Protocol development and amendments
Clinical trial strategy
Good Clinical Practices (GCP)
Data integrity and safety monitoring
Investigator and site engagement
Nice-to-have
Enhanced Clinical Trial Design
Quantitative Drug Development
Cross-functional collaboration
Regulatory compliance
Mentoring and leadership
Key Requirements
M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent
Postgraduate training/fellowship preferred
Demonstrated scientific productivity
Understanding of local/international regulations
Experience in clinical trial strategies and processes
Track record of study design, oversight, and interpretation
Leadership or management experience preferred
Knowledge and experience in GCP
Experience in clinical trial conduct and execution