THE OPPORTUNITY
Senior Director, Clinical Research Oncology
What You'll Do
- Serve as the Clinical Science functional leader for one or more oncology programs across early and/or late-stage development.
- Define and drive clinical development strategies, including indication selection, study design, endpoints, and lifecycle planning.
- Provide clinical and scientific leadership across all phases of development (Phase 1, dose expansion, registrational, and post-approval studies).
- Ensure integration of clinical, translational, pharmacology, biometrics, and regulatory perspectives into cohesive development plans.
- Oversee clinical science deliverables (protocols/amendments, ICFs, CRF design and data review strategies, CSRs, and clinical sections of regulatory submissions).
- Guide ongoing clinical data review, interpretation, and risk assessment; escalate key findings and safety signals as appropriate.
- Partner with Clinical Operations to ensure high-quality study execution and timelines.
- Act as clinical science representative on program teams and governance forums; drive cross-functional alignment.
- Present and defend clinical strategy/data to internal governance, executive leadership, and external stakeholders.
- Serve as scientific interface with investigators/KOLs, advisory boards/steering committees, and regulatory agencies; support regulatory interactions and scientific meetings.
- Lead, mentor, and develop clinical scientists; contribute to scaling the Clinical Science function.
Who You Are And What You Bring
- MD, PhD, or PharmD in a relevant discipline (Oncology, Immunology, Pharmacology, Molecular Biology).
- 12+ years oncology clinical research/drug development experience (pharma/biotech/academic/CRO).
- Demonstrated leadership of early- and late-stage clinical development programs.
- Proven clinical science/program lead capability with strategy and execution accountability.
- Experience with regulatory submissions/interactions (strongly preferred).
- Deep understanding of oncology trial design/execution, GCP/ICH, clinical data interpretation, safety evaluation, and benefit-risk assessment.
- Strong translational and biomarker strategy knowledge.
- Collaborative cross-functional leadership track record.