Senior Global Oncology Clinical Development Leader

Regulatory Jobs; Gaithersburg (MD); Híbrido; USD 234.000 - 350.000; Tempo integral

Resumo da vaga

AstraZeneca is seeking a Senior Global Clinical Development Scientist Director to shape late-phase oncology trials that reach patients worldwide. You will drive protocol development, science strategy, and regulatory interactions from concept through to submission, partnering with cross-functional teams across multiple countries.

Ideal candidates will have extensive oncology drug development experience, strong knowledge of FDA/ICH/GCP, and a track record of leading complex, global programs with

Qualificações

• PharmD, Ph.D. degree in life sciences, or MD preferred.
• 7+ yrs industry or academic experience in drug development.
• Foundational knowledge of FDA and major country regulations.
• Knowledge of Good Clinical Practice (GCP) and related regulations.

Responsabilidades

• Translate program strategy into high-quality study concepts, protocols, and related materials (ICFs, CRFs, TFL shells).
• Own scientific rationale and clinical integrity of protocols and plans; secure governance approvals.
• Drive study initiation and execution with cross-functional teams; manage feasibility and site selection.
• Lead study-level medical monitoring and safety reviews to protect participants and data quality.
• Support health authority interactions and regulatory submissions; contribute to NDA/BLA packages.

Formação

PharmD, Ph.D. in life sciences, or MD

Descrição da vaga

AstraZeneca is seeking a Senior Global Clinical Development Scientist Director to shape late-phase oncology trials that reach patients worldwide. You will drive protocol development, science strategy, and regulatory interactions from concept through to submission, partnering with cross-functional teams across multiple countries.

Ideal candidates will have extensive oncology drug development experience, strong knowledge of FDA/ICH/GCP, and a track record of leading complex, global programs with