Senior Director, Clinical Development

Senior Director, Clinical Development

Responsibilities
- Lead clinical development strategy and execution for assigned clinical-stage oncology asset(s), partnering cross-functionally to create and implement comprehensive clinical development plans
- Provide medical and scientific leadership for development programs
- Design, author, and oversee 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 primary clinical lead for investigators and KOLs
- Lead clinical contributions to regulatory submissions (INDs, CTAs, NDA/MAA filings) and Health Authority interactions
- Act as Medical Monitor and/or oversee external Medical Monitors to ensure appropriate medical oversight and patient safety
- Provide oversight of adverse event review, safety monitoring, protocol compliance, and clinical data evaluation
- Partner with Clinical Operations, Clinical Pharmacology, Biometrics, Regulatory Affairs, Drug Safety, Data Management, Quality, and Translational Sciences
- Analyze/interpret clinical trial data and communicate findings via regulatory submissions, publications, congress presentations, and internal governance reviews
- Lead responses to Health Authorities, Ethics Committees, and IRBs
- Contribute to portfolio strategy, development planning, and broader organizational initiatives as needed

Qualifications
- MD required; board certification/eligibility in Medical Oncology, Hematology/Oncology, or related specialty strongly preferred
- 5+ years clinical development experience in biotech/pharma, including leading oncology development programs
- Experience designing, executing, interpreting, and reporting oncology clinical trials (targeted therapies, small molecules, and/or immuno-oncology)
- Experience supporting/leading late-stage programs and NDA/BLA/MAA submissions with Health Authority interactions
- Strong understanding of biological/translational sciences in oncology (molecular biology, cancer genetics, immunology, precision medicine)
- Proven ability to lead/influence cross-functional teams in a matrixed organization
- Excellent strategic, organizational, and project leadership; strong problem-solving
- Exceptional communication/presentation with senior leadership, investigators, KOLs, and regulators
- Collaborative, results-driven leadership
- Flexible, resourceful, entrepreneurial mindset

Salary range: $274,400—$411,600 USD