Clinical Operations (AD, Director, Sr Director)
$200,000–$270,000 year
Hybrid · New York City, New York, United States
Job Summary
Clinical Operations leader for a high-priority program based in the New York City area with flexibility for hybrid work. Responsible for overseeing all aspects of clinical operations across multiple studies (Phase I-III), developing operational strategy, managing external partners/CROs, and ensuring timely, high-quality execution within budget. Lead cross-functional collaboration with Clinical Development, Regulatory, Biostatistics, Translational Medicine, and Program Leadership; contribute to Clinical Development Plans and development of study documents (protocols, data monitoring plans, Investigator Brochure, IND/NDA/MAA updates). Requires extensive experience managing clinical trials, strong vendor oversight, and a track record of operational leadership in sponsor/CRO environments. The role requires proximity to NYC, Philadelphia, or Boston areas, with a hybrid arrangement of office visits, remote work, and travel to sites as needed.
Required Qualifications
- 10+ years of clinical research / project management experience
- experience managing outsourced clinical trials with budget, timeline, and quality expectations
- understanding of clinical protocol development, regulatory submissions, and drug development
- ability to establish operational plans and support CRO/vendors in execution
- familiarity with Phase I-IV clinical development and cross-functional collaboration
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