Senior Director, Clinical Development
About The Position
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.
Requirements
- M.D., M.D./Ph.D., with a specialization in Medical Oncology or Hematology/Oncology.
- 7+ years in clinical development within the biotech or pharmaceutical industry.
- Deep knowledge in IO therapies for oncology
- Proven ability to thrive in a "player-coach" role within a fast-paced, startup environment.
- Expert understanding of GCP, ICH guidelines, and global regulatory requirements.
Responsibilities
- Lead the creation of Clinical Development Plans (CDPs) and design and draft Phase I–III clinical trial protocols for IO assets, ensuring scientific rigor and alignment with corporate goals.
- Serve as the primary Medical Monitor for assigned studies, overseeing patient safety, reviewing SAEs, and providing expert medical judgment on clinical data.
- Provide expert medical management of Immune-Related Adverse Events (irAEs), such as cytokine release syndrome (CRS) or neurotoxicity, and develop toxicity management guidelines.
- Act as the lead clinical representative for interactions with health authorities (e.g., FDA, EMA), and author key clinical sections for IND, NDA, and BLA submissions.
- Partner closely with Clinical Operations, CMC, and Regulatory Affairs to ensure study milestones are met on time and within budget.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
