Senior Director, Global Clinical Development Scientist
Core
Shape late-phase oncology trials, design pivotal studies, and translate clinical strategy into protocols and data-driven decisions for patients, clinicians, and regulators.
Role type
Senior Director, Global Clinical Development Scientist (Oncology)
Builds
Late-phase oncology clinical trials and pivotal studies
Domain
Life Sciences / Oncology / Clinical Development
Required skills
Clinical strategy translation, Protocol ownership and integrity, Trial delivery and recruitment, Safety and medical monitoring, Data review and decision-making, Regulatory and registration support, Cross-functional leadership, Process improvement and mentorship
Preferred skills
Independent leadership of complex clinical development plans, Protocol design and implementation per GCP/ICH, Advanced trial designs (adaptive, biomarkers), Global matrixed team operation, Mentoring clinical staff, Stakeholder consensus building
Technologies
GCP, ICH, FDA regulations, NDA/BLA, IDMC, EC/IRB
Responsibilities
Convert program strategy into study concepts and protocols; ensure scientific rationale and integrity of clinical plans; drive study initiation, execution, and recruitment; lead medical monitoring and safety reviews; lead clinical data reviews and study reports; support regulatory submissions and health authority interactions; partner with investigators and MSLs for feasibility; mentor team members.
Seniority
Senior Director, hands-on IC with line management