Senior Director, Clinical Development

Your Role

Lead the clinical development strategy and execution for assigned clinical-stage oncology asset(s), partnering with cross-functional teams to create and implement comprehensive clinical development plans

Provide leadership to the clinical team and serve as the medical and scientific expert for development programs

Design, author, and oversee the development of study protocols, protocol amendments, investigator brochures, and other key clinical documents in compliance with project plans, global regulations, ICH/GCP guidelines, and Good Medical Practice

Serve as the primary clinical lead for study investigators and key opinion leaders, building strong relationships that support program success and scientific advancement

Lead clinical contributions to regulatory submissions, including INDs, CTAs, NDA/MAA filings, and interactions with Health Authorities

Act as Medical Monitor and/or oversee external Medical Monitors for company-sponsored clinical trials, ensuring appropriate medical oversight and patient safety

Provide strategic oversight of adverse event review, safety monitoring, protocol compliance, and clinical data evaluation

Partner closely with Clinical Operations, Clinical Pharmacology, Biometrics, Regulatory Affairs, Drug Safety, Data Management, Quality, and Translational Sciences to ensure integrated and efficient execution of development programs

Analyze and interpret clinical trial data and communicate findings through regulatory submissions, scientific publications, medical congress presentations, and internal governance reviews

Lead responses to questions from Health Authorities, Ethics Committees, and Institutional Review Boards, ensuring consistency and scientific rigor

Contribute to portfolio strategy, development planning, and broader organizational initiatives as needed

What You Bring

• MD required; board certification or board eligibility in Medical Oncology, Hematology/Oncology, or a related specialty strongly preferred
• 5+ years of clinical development experience within the biotechnology and/or pharmaceutical industry, including experience leading oncology development programs
• Demonstrated experience in the design, execution, interpretation, and reporting of oncology clinical trials involving targeted therapies, small molecules, and/or immuno-oncology agents
• Experience supporting or leading late-stage clinical development programs, NDA/BLA/MAA submissions, and Health Authority interactions
• Strong understanding of the biological and translational sciences underlying modern oncology drug development, including molecular biology, cancer genetics, immunology, and precision medicine approaches
• Proven ability to lead and influence cross-functional teams within a matrixed organization
• Excellent strategic thinking, organizational, and project leadership skills, with the ability to balance high-level planning and hands-on execution
• Strong problem-solving skills and the ability to identify innovative approaches to advance development programs and organizational objectives
• Exceptional communication and presentation skills, including the ability to engage effectively with senior leadership, investigators, KOLs, and regulatory agencies
• Demonstrated leadership capabilities with a collaborative, team-oriented, and results-driven approach
• Flexible, resourceful, and entrepreneurial mindset with the ability to thrive in a dynamic and fast-paced biotechnology environment