Description
This role is responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.
The Medical Director, Safety Physician - Oncology will lead the development and implementation of clinical safety strategies for assigned drug projects and products, ensuring compliance with regulatory requirements and company policies.
Key responsibilities include:
- Developing and implementing clinical safety strategies for assigned drug projects and products
- Providing medical input to regulatory supporting documentation for labelling updates
- Collaborating with external provider representatives in routine signal management activities
- Discussing the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders
- Providing medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
The ideal candidate will have a medical degree (e.g. MD, MBBS) and at least 2 years of clinical experience post-registration, with a high level of medical competence and an ability to balance this with industry standards to achieve business goals.
The role requires strong communication and collaboration skills, with the ability to work effectively in cross-functional and cross-cultural project teams and environments.
The Medical Director, Safety Physician - Oncology will be accountable for maintaining personal readiness in response to internal audit or regulatory inspection, and will participate in, and may lead, a process improvement initiative team within PS.