Key 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.