Responsibilities Clinical Strategy & Design : 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. Medical Monitoring : 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. Regulatory Leadership : 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. Cross-Functional Collaboration : Partner closely with Clinical Operations, CMC, and Regulatory Affairs to ensure study milestones are met on time and within budget. Qualifications & Skills Education : M.D., M.D./Ph.D., with a specialization in Medical Oncology or Hematology/Oncology . Experience : 7+ years in clinical development within the biotech or pharmaceutical industry. Therapeutic Expertise : Deep knowledge in IO therapies for oncology. Mindset : Proven ability to thrive in a "player-coach" role within a fast-paced, startup environment. Compliance : Expert understanding of GCP, ICH guidelines, and global regulatory requirements. #J-18808-Ljbffr