Medical Director, Patient Safety Physician

Location: Gaithersburg or Boston

Hybrid: 3 days a week online

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. 

When we put unexpected teams in the same room, we unleash 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.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. 

The Role:

The Medical Director, Senior Patient Safety Physician leads the Clinical Safety strategy for assigned AstraZeneca-MedImmune products across development and post‑marketing, ensuring implementation and communication at project/governance levels. The role oversees ongoing safety assessment, signal detection, risk evaluation and management, and consistent communication across regulatory safety documents (e.g., PBRERs, PADERs, DSURs). It includes proactive evaluation of safety data from pre‑clinical and clinical sources, collaboration with cross‑functional experts and Safety Management Teams, contribution to the pharmacovigilance system (including QPPV interface), and engagement with external opinion leaders. 

The principal accountabilities/responsibilities are summarized below:

Safety Governance and Risk Management activities

• Working with the Safety Team, be 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 safety strategy at the project team/governance level. Activities include, but are not limited to: definition of identified and potential risks, proposals for mitigation and minimisation measures,, safety go-no-go criteria for the clinical programme, input to TPP/TPC,, safety submission strategies, response to regulatory safety queries and definition of risk component of the benefit/risk assessment

• Reviews and endorses the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).

• Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, MedImmune dRMP, CPRL and globally reviewed LRMPs.

• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.

• Leads medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.

• Leads strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.

• Leads strategic and medical input to project specific safety requirements (PSSR).

• Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.

• Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.

• May present safety information at clinical investigator and commercial meetings.

• Facilitates establishment of a Safety Management Team/MedImmune Safety Review Team as necessary.

Signal Detection, Evaluation and Labelling

• Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities (or Medimmune equivalent) for all products in area or responsibility.

• Provides medical input to regulatory supporting documentation for labelling updates.

• Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.

• Sets the strategy for routine signal management activities.

• Presents th