About this role
About the Role The Senior Director sits within Global Oncology Clinical Development, providing medical accountability and oversight for one or more oncology trials. The role guides strategy, design, execution, and interpretation of oncology clinical trials, and contributes to lifecycle management and product positioning aligned with the Target Product Profile. What You'll Do
- Medical Monitoring: Provide medical input on study and country feasibility, site feasibility assessments; contribute to eCRF design, UAT, and CRF Completion Guidelines; conduct ongoing clinical data review and assess protocol deviations; address medical queries from sites/IRBs including eligibility, safety, dose modifications, and AE management; oversee CRO Medical Monitor activities and data review.
- Clinical Development Expertise & Strategy: Lead the development and execution of the Clinical Development Plan (CDP) ensuring alignment with protocols and the Target Product Profile (TPP); provide medical/scientific leadership for study design, protocol development, and key study-level documents (CSR, IB, regulatory responses); interpret and present clinical data to internal/external stakeholders; support regulatory and safety reporting (DSUR, PSUR); deliver scientific training and lead key study meetings (IM, SIV); maintain deep therapeutic area expertise and contribute to strategic insights on disease landscape, competition, and product positioning; lead engagement with governance bodies (DMC, Steering Committee) including charter development and oversight; oversee external partnerships (CROs, AROs, cooperative groups) and contribute to labeling/product lifecycle management.
- Health Authority Interactions & Publications: May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, and regulatory interactions (FDA, MHRA, EMA, PMDA); may support overall publication and clinical communication strategy and provide input to external presentations; serves as the medical point of expertise in key Health Authority interactions and Ad board meetings. What We're Looking For
- Education: MD required; Postgraduate training in TA or related specialty required.
- Experience: 7 or more years of relevant clinical experience required.
- Travel: Ability to travel up to 20% of the time; domestic and international travel required.
- Additional: Demonstrated leadership for Phase 1–3 studies, strong cross-functional collaboration, and ability to interact with regulatory agencies; oncology/domain expertise strongly preferred. Compensation & Benefits
- Salary Range: USD 280,350.00 – USD 467,250.00 per year.
- Benefits: Benefits summary available (PDF download referenced in posting).