THE OPPORTUNITY
The Senior Director, Clinical Research Oncology will provide strategic and operational leadership for the Clinical Science function within Oncology Clinical Development. You will be accountable for shaping and executing clinical development strategies across oncology programs, ensuring scientific rigor, regulatory alignment, and efficient delivery of high‑quality clinical data.
This role requires an experienced MD, PhD or PharmD with deep expertise in oncology drug development and a proven track record of leading clinical research teams through complex development programs, from first‑in‑human through registration.
WHAT YOU'LL DO
Clinical Science & Development Leadership
- 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, including Phase 1, dose expansion, registrational, and post‑approval studies.
- Ensure integration of clinical, translational, pharmacology, biometrics, and regulatory perspectives into cohesive development plans.
Study & Program Oversight
- Oversee clinical science deliverables for assigned studies, including protocols and amendments, informed consent forms (ICFs), case report form (CRF) design and data review strategies, and clinical study reports (CSRs) as well as the clinical sections of regulatory submissions.
- Guide ongoing clinical data review, interpretation, and risk assessment, escalating key findings and safety signals as appropriate.
- Partner closely with Clinical Operations to ensure high‑quality study execution, timelines, and decision‑
Cross ‑ Functional & Governance Leadership
- Act as the clinical science representative on program teams, clinical development sub‑teams, and governance forums.
- Drive alignment and decision‑making across Clinical Operations, Biometrics, Translational Medicine, Clinical Pharmacology, Regulatory, Safety, and Medical Writing.
- Present and defend clinical strategy and data to internal governance committees, executive leadership, and external stakeholders.
External Engagement
- Serve as a key scientific interface with investigators and key opinion leaders (KOLs), advisory boards and steering committees, and regulatory agencies, as needed.
- Support preparation for and participation in regulatory interactions and scientific meetings.
People & Functional Leadership
- Lead, mentor, and develop clinical scientists, fostering scientific excellence, accountability, and career growth.
- Contribute to building and scaling the Clinical Science function, including process development, talent strategy, and best practices.
WHO YOU ARE AND WHAT YOU BRING
- MD, PhD, or PharmD in a relevant scientific or medical discipline (e.g., Oncology, Immunology, Pharmacology, Molecular Biology).
- 12+ years of experience in oncology clinical research and drug development in a pharmaceutical, biotechnology, academic, or CRO environment.
- Demonstrated experience leading both early‑ and late‑stage clinical development programs.
- Proven ability to serve as a clinical science or program lead, with accountability for strategy and execution.
- Experience contributing to or leading regulatory submissions and interactions is strongly preferred.
- Demonstrate a deep understanding of oncology clinical trial design and execution, GCP/ICH guidelines and regulatory expectations, and clinical data interpretation, safety evaluation, and benefit‑risk assessment.
- Strong knowledge of translational and biomarker strategies that inform clinical development decisions.
- Collaborative leader with a track record of effective cross‑functional partnership
