Associate Director, Clinical Operations
Generate Biomedicines · Remote
Clinical OperationsRemoteCompany career page
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Role summary
Generate Biomedicines seeks an Associate Director of Clinical Operations to lead early-stage oncology trial planning and execution. The role involves managing clinical operations strategy, overseeing CRO and site relationships, ensuring GCP compliance, and leading an operations team.
What they're looking for
- Minimum 8 years clinical operations experience across at least 2 therapeutic areas including oncology
- Experience managing CROs and vendors in US and international clinical trials
- Site initiation visit, site management, and regulatory data management experience
- Understanding of drug development from IND through NDA
- Strong collaborative and communication skills in fast-paced environment
- Large pharma and biotech background preferred; biomarker-selected study experience preferred
What you'll be doing
- Develop and execute clinical operations strategy for assigned oncology program
- Evaluate and manage external collaborators including CROs and clinical sites
- Develop SOPs, manage timelines, and ensure GCP compliance across studies
- Lead clinical operations team and mentor staff members on program
- Coordinate cross-functional collaboration on protocols, regulatory submissions, and clinical reports
Privacy & handoff
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