Global Development Medical Director, Late Oncology
Global Development Medical Director, Late Oncology
AstraZeneca
Gaithersburg, MD
See who AstraZeneca has hired for this role
As a Global Development Medical Director in Late Phase Oncology R&D you will:
- Be responsible for ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance regulatory guidelines and contribute to medical review and monitoring activities.
- Work cross functionally within clinical product teams to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents.
- Develop relationships with appropriate consultants and key external experts (KEE), study sites, and use these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results, and inform recruitment strategies.
- Be responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
- Support or lead interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.
Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
Research: Demonstrates understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research and can conduct literature reviews to inform protocols, and author background sections on the disease or current medical therapy.
Presentation and Communication: Ability to prepare and present clinical data, training sessions to internal and external audiences and to contribute to clinical reports and integrated summary reports. Ability to clearly communicate scientific concepts/data to leadership committees (e.g., LSPC, DRC, PRC) or external groups (e.g., Investigator Meetings, IDMCs, Conferences Presentations.)
Required Qualifications:
- Required M.D or MD./Ph.D. degree or equivalent. Strong preference for individuals with clinical training in oncology
- 2 years of Industry or academic experience in drug development
- Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
- Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
- Ability to grow and maintain a high level of expertise in oncology therapeutic area
Why AstraZeneca?
Join the team at the heart of AstraZeneca that is committed and encouraged to follow the science. Driven by our curiosity, passion and determination we are paving the way to change the practice of medicine in Oncology. As Clinical Development Physicians and Scientists in Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Health Care Provider -
Industries
Pharmaceutical Manufacturing
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