Co-chairs clinical study teams and provides clinical and scientific expertise to strategy and protocol development, ensuring efficient clinical protocols through Enhanced Clinical Trial Design
Job Summary
Co-chairs clinical study teams and provides clinical and scientific expertise to strategy and protocol development, ensuring efficient clinical protocols through Enhanced Clinical Trial Design.
Identifies and assesses study risks to GCP, subject rights, and data integrity, creating and implementing mitigation plans, and oversees the work of the Study Team.
Conducts clinical review and interpretation of efficacy and safety data, ensuring the clinical and scientific validity of study reports and appropriate disclosure of data.
Matching Summary
Co-chairs clinical study teams and provides clinical and scientific expertise to strategy and protocol development, ensuring efficient clinical protocols through Enhanced Clinical Trial Design.
Skills & Requirements
Must-have
Clinical study design and conduct
Protocol development and amendments
Study risk assessment and mitigation
Clinical data interpretation and reporting
Regulatory compliance for clinical trials
Investigator and site engagement
Nice-to-have
Enhanced Clinical Trial Design
Quantitative Drug Development
Cross-functional collaboration
Mentorship and coaching
Scientific and commercialization support
Key Requirements
M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent qualifications
Postgraduate training, certification or fellowship preferred
Demonstrated scientific productivity
Thorough understanding of local and international regulations
Practical experience in clinical trial strategies
Track record of design, oversight and interpretation of clinical studies
Previous leadership or management experience or training
Knowledge and experience in Good Clinical Practices (GCP)
Experience in conduct and execution of clinical trials