Key Responsibilities
- Strategic leadership: Oversee development of early pipeline assets (IO targets, ADCs, TCEs, small molecules); mentor 3β5 direct reports (medical directors and/or early development team leads); represent programs in senior management/governance forums; support safety assessment for Phase 1 designs, biomarker characterization, and dose finding; present data to Pipeline Governance and senior management; evaluate new compound opportunities for BD/acquisitions (risks/opportunities).
- Clinical Development Plan (CDP): Develop and execute end-to-end clinical plans, including Phase 1/2 trial design, IND submissions, and Investigator Brochures.
- Cross-functional collaboration: Partner with Discovery, Translational Medicine, Clinical Pharmacology, Regulatory, and Operations to ensure efficient trial execution.
- Scientific/medical expertise: Analyze patient data, including PK/PD modeling and biomarkers, to optimize dosing and compound strategy.
- Talent management: Mentor and provide feedback to build high-performing teams.
- External outreach and leadership: Stay current with industry trends and emerging technology through conferences and literature; assess competitive environment impact on programs.
Education
- MD or MD/PhD with a strong background in oncology and early drug development.
Required Experience and Skills
- 10+ years industry experience (preferably 5+ in oncology early development).
- Deep knowledge of Phase 1/early development trial methodology; regulatory/compliance requirements; clinical strategy and protocol design.
- Strong oncology drug development background; experience across multiple MoAs (small molecules, biologics including ADCs and TCEs) and design/conduct of oncology early trials.
- Proven leadership, ability to lead through influence, delegate decision-making.
- Collaboration, executive function, problem-solving; respectfully challenge teams for risks/mitigations.
- Commitment to training junior staff; support global scientific/business strategy; oversee multiple complex clinical research programs.
- Excellent oral and written communication.