The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trials and their delivery, clinical data review, interpretation of results, and activities required for worldwide registration of the product. The role plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. You will work collaboratively with teh Global Development Scientists in the clinical aspects underpinning a product.
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.
To be successful, you will need to demonstrate capability in the following technical areas:
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
When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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.
Date Posted
02-Oct-2024Closing Date
24-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.