Associate Director, Clinical Scientist
Core
Lead the planning and execution of clinical trials from start-up through close-out, serving as the clinical knowledge hub and primary liaison for external partners.
Role type
Senior IC clinical scientist (Associate Director)
Builds
Clinical trials and regulatory documents for innovative medicines
Domain
Biopharmaceuticals / Clinical Development
Required skills
GCP/ICH guidelines, study design, statistics, protocol development, data review and validation, clinical narrative planning, medical writing, data monitoring committees, disease area expertise
Preferred skills
MD, PhD, PharmD, MS, RN, 5+ years clinical science experience, RAVE/J-Review tools
Technologies
RAVE, J-Review, Microsoft Office
Responsibilities
Lead planning and execution of study activities across multiple trials; Collaborate on protocol and Informed Consent Form development; Oversee data generation and validation activities; Develop clinical narrative plans; Support site-facing activities and training; Contribute to drafting and validation of Clinical Study Reports and regulatory documents; Evaluate innovative trial designs; Support study committee activities
Seniority
Senior, hands-on IC