Responsibilities
- Provide strategic leadership for early pipeline assets (e.g., IO targets, ADCs, TCEs, small molecules); mentor medical directors/early development leads; represent programs in senior management/governance forums.
- Advance programs from candidate stage to clinical proof-of-concept; oversee timelines/risks and interpret data to support go/no-go decisions; assess new compound opportunities for BD/acquisitions (risks/opportunities).
- Develop and execute end-to-end clinical development plans (Phase 1/2 design, IND submissions, Investigator Brochures).
- Collaborate with Discovery, Translational Medicine, Clinical Pharmacology, Regulatory, and Operations to ensure effective trial execution.
- Apply scientific/medical expertise: analyze patient data, PK/PD modeling, and biomarkers to optimize dosing/strategy.
- Manage talent: mentor and provide feedback to build high-performing teams.
- Conduct external outreach (conferences/literature/training) to stay current on industry trends and competitive landscape.
Education
- MD or MD/PhD with strong background in oncology and early drug development.
Required Qualifications/Experience
- 10+ years industry experience (preferably 5+ years oncology early development).
- In-depth knowledge of Phase 1 trial methodology; regulatory/compliance requirements; clinical strategy and protocol design.
- Strong oncology drug development background; experience with multiple modalities (small molecules, biologics incl. ADCs/TCEs) and oncology early clinical trial design/conduct.
- Proven leadership; ability to lead/manage through influence; delegate decision-making.
- Strong collaboration, problem-solving, and communication.
- Ability to respectfully challenge teams to assess opportunities/risks/mitigations.
- Commitment to training junior staff; autonomy-appropriate judgment.
- Ability to oversee multiple complex clinical research programs.