Senior Director, Clinical Development (U.S. Remote)

Clinical Strategy And Development LeadLead 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.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.