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

Key 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.

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.