About this role
About the Role The Senior Director sits within Global Oncology Clinical Development, overseeing medical accountability and oversight for one or more oncology clinical trials. The role includes matrix management across internal and external networks, leading Phase 1–3 studies as assigned, and providing medical and scientific expertise to cross-functional teams.
What You'll Do
- Provide medical input on study feasibility, site feasibility assessments, and eCRF design, UAT, and CRF Completion Guidelines as needed.
- Conduct ongoing clinical data review, assess protocol deviations, address medical queries from sites/IRBs (eligibility, safety, dose modifications, AE management); serve as study medical expert and oversee CRO Medical Monitor activities.
- Lead development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP). Provide medical leadership for study design, protocol development, and key study-level documents (CSR, IB, regulatory responses).
- Interpret and present clinical data to internal and external stakeholders; support regulatory and safety reporting (DSUR, PSUR); deliver scientific training and lead key study meetings (IM, SIV).
- Maintain deep therapeutic area expertise; contribute to strategic insights on disease landscape, competition, and product positioning (TPP/EPP).
- Lead engagement with governance bodies (DMC, Steering Committee), including charter development, presentations, and ongoing oversight.
- Oversee external partnerships (CROs, AROs, cooperative groups) and contribute to labeling and product lifecycle management.
- May contribute to Health Authority interactions and Ad board meetings; support publication strategy and external presentations.
What We're Looking For
- MD required.
- Postgraduate training in TA or related specialty required.
- 7+ years of relevant clinical experience required.
- Experience in Hematology preferred.
- Ability to travel up to 20%.
Nice to Have
- Hematology experience preferred.
Compensation & Benefits
- Salary not disclosed.