THE OPPORTUNITY
Senior Director, Clinical Research Oncology β Clinical Science functional leadership within Oncology Clinical Development.
What You'll Do
- Serve as Clinical Science functional leader for one or more oncology programs across early- and/or late-stage development.
- Define and drive clinical development strategies: indication selection, study design, endpoints, and lifecycle planning.
- Provide clinical/scientific leadership across 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 & data review strategy, CSRs, and clinical sections of regulatory submissions.
- Guide clinical data review, interpretation, and risk assessment; escalate key findings and safety signals as appropriate.
- Act as clinical science representative on program teams/governance forums.
- Drive alignment with Clinical Operations, Biometrics, Translational Medicine, Clinical Pharmacology, Regulatory, Safety, and Medical Writing.
- Present and defend clinical strategy/data to internal governance committees, executive leadership, and external stakeholders.
- Interface with investigators/KOLs, advisory boards/steering committees, and regulatory agencies as needed.
- 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 relevant discipline (e.g., Oncology, Immunology, Pharmacology, Molecular Biology).
- 12+ years oncology clinical research/drug development in pharma/biotech/academic/CRO.
- Experience leading early- and late-stage clinical development programs.
- Ability to serve as clinical science or program lead with strategy/execution accountability.
- Regulatory submissions/interactions experience strongly preferred.
- Deep knowledge of oncology trial design/execution; GCP/ICH; regulatory expectations; data interpretation, safety evaluation, benefit-risk assessment.
- Knowledge of translational and biomarker strategies.
- Collaborative cross-functional leadership track record.
Compensation/Benefits
- Expected salary range: $235,500β$329,500 per year.
- Benefits include compensation, bonus and equity; health/welfare plans; non-accrual paid time off; company holiday shut down; commuter benefits; 401K match; lunch in office.