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Associate Director, Clinical Operations

Generate:Biomedicines
September 21, 2026
Full-time
Remote friendly (Somerville, MA)
Worldwide
Clinical Research and Development
Role: Associate Director of Clinical Operations leading early-stage oncology clinical trials, responsible for study planning, execution, and stakeholder collaboration. Core responsibilities include developing clinical strategies, managing CROs and external vendors, ensuring GCP compliance, overseeing study timelines, and mentoring clinical operations staff. The candidate will serve as the program lead for at least one clinical trial, interfacing across cross-functional teams for regulatory submissions, safety reports, and study documentation. Requirements: minimum 8 years in clinical operations, with experience in oncology and managing international CROs and sites; strong understanding of drug development from IND to NDA; proven leadership in fast-paced environments. Preferred: experience with biomarker-driven studies and biotech/pharma settings. High-Value: oncology indications, early development stages, CRO/vendor management, regulatory compliance, cross-functional collaboration, and global trial oversight. Work setup and travel details are not specified.