Prepare clinical development plans according to the nature of the clinical project and its objectives
Oversee protocol development from concept to final protocol
Serve as sponsor contact for key study sites on protocol related topics
Write, edit, and review medical and scientific elements of both internal and external facing documents inclusive of clinical research
Manage Key Opinion Leader and Medical Advisory Board interactions
Assist Clinical Operations with supervision of activities of contract research organizations by reviewing key study plans and performance/quality
Requirements
MD, DO, PhD, PharmD or equivalent degree or experience
At least 7-10 years of demonstrated clinical research and clinical development experience required
Working knowledge of the assigned disease area with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trial(s)
Working knowledge of region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.) and ICH GCP guidelines
Strong project management and medical writing skills
Proficiency in MS Office Suite (Word, Excel, PowerPoint) and Adobe Pro
Ability to travel domestically and internationally, as required (approximately 25%)