Vice President, Clinical Development, Oncology

What you'll do

• Set clinical strategy and lead IND/CTA planning, Phase 1 study design and execution, and progression toward registrational development.
• Establish biomarker and patient-selection strategies, applying AI and advanced analytics where useful in trial design and clinical decisions.
• Build and lead the clinical development team, oversee safety and regulatory engagement, and manage external partners and resources.

What they ask for

• MD or MD/PhD.
• At least 12 years of biotechnology or pharmaceutical clinical development experience, including at least 5 years in a leadership capacity with program and direct-report accountability.
• Oncology experience across more than one tumor type, including patient dose-finding and dose-optimization studies; led clinical strategy and authored content for at least one oncology IND or CTA and served as clinical lead through first-in-human study.
• Advanced at least one oncology program from Phase 1 into successful late-stage or registrational development; demonstrated biomarker strategy experience, direct AI/advanced analytics application, and extensive regulatory experience including direct FDA interaction.

Nice to have

• Residency and fellowship in medical oncology or hematology/oncology, with board certification; contribution to an approved oncology therapeutic.
• Experience with novel therapeutic modalities, companion diagnostic co-development, adaptive or model-informed development, AI-native biotech, or establishing an early clinical development function.

Pay

USD $350,000 to $407,000 annually (base pay)

Tools

BOIN, mTPI, Bayesian model-based designs, FDA Project Optimus, X-patient

AI focus

Apply AI, computational biology, and advanced analytics to clinical strategy, trial design, biomarker and patient selection, dose selection, and evidence generation; assess model validity and limitations, and ensure appropriate data quality, explainability, bias assessment, and human oversight.