Medical Director, Patient Safety Physician

Job Title: Medical Director, Patient Safety Physician

GCL: F

Introduction to role:

Are you ready to set the clinical safety strategy that protects patients and accelerates life-changing medicines? In this role, you will lead the end-to-end safety strategy for assigned medicines across development and post-marketing, crafting clear, evidence-based decisions that keep patients safe while enabling swift, confident progress. Your leadership will ensure risks are identified early, mitigations are robust, and benefit–risk assessments are detailed and actionable.

You will join a fast paced, empowered team advancing innovative therapies for some of the hardest-to-treat cancers. Here, decisions are made at pace and backed by data. When the world needed answers during a global health crisis, our teams mobilised within weeks to design studies, run analyses and publish findings. Could you bring that same vitality and clarity to our pipeline, leading the safety profile that underpins regulatory success and real-world impact?

Accountabilities:

• Define, implement and communicate the clinical safety strategy for assigned medicines in late-stage development and on-market, including risk identification, high-level mitigation and minimisation, safety go/no-go criteria, and contributions to benefit–risk assessments at project and governance forums.
• Review and endorse the core Patient Risk Management Plan, chipping in medical expertise to the safety specification, pharmacovigilance plan and risk minimisation activities across core, development and locally reviewed plans; ensure risk-minimisation strategies are accurately reflected in reference safety information.
• Represent Patient Safety on clinical and project teams. Offer strategic and medical mentorship for development plans and safety requirements. Review and approve investigator brochures, protocols, informed consents, and final reports. Support Safety Management/Review Teams to resolve critical issues.
• Take charge of or support surveillance activities, including medical review of individual cases, signal detection, and SIRC activities. Identify and use appropriate data sources. Collaborate with external providers. Synthesize findings into clear, fit-for-purpose evaluations and recommendations.
• Provide medical input to labelling updates, respond to regulatory requests for local label deviations, and prepare Developmental Core Safety Information for development products in consultation with Patient Safety scientists and Clinical collaborators.
• Provide medical input and review for PBRERs, PSURs, DSURs and renewal documentation; lead Patient Safety contributions to global submissions (NDA, BLA, MAA, and others), ensuring consistency and clarity of safety topics across all regulatory documents.
• Understand the role of the QPPV and give to maintaining a compliant, inspection-ready pharmacovigilance system and processes; ensure readiness for audits and inspections and escalate issues appropriately and promptly.
• Support interactions with opinion leaders, consultants and partners; contribute to licensing agreements and Safety Agreements; participate in external regulatory and non-regulatory meetings and, when needed, assist in due diligence and product liability activities.
• Lead or contribute to process improvement initiatives; generate and implement ideas that advance safety science and ways of working; mentor and train junior colleagues in signal evaluation, risk management and safety reporting; foster effective collaboration across functions and cultures.

Essential Skills/Experience:

• Medical degree (eg MD, MBBS)
• 15+ years of Patient Safety experience (with clear evidence of delivery) in which at least 2 years of clinical experience post-registration preferred
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities

Desirable Skills/Experience:

• Commitment to Customers and Integrity; Strategic Leadership; Acts Conclusively; Drives Accountability; Works Collaboratively; Develops People and Organisation
• Drug Development Experience and Application of Disease and Therapy Area knowledge; Integrative thinking; Excellence in pharmacovigilance; Patient benefit–risk assessment
• Core: Conceptual thinking; Influencing and negotiation; Initiative; Innovation and awareness of emerging practices; Business relationship management and development of strategic, collaborative partnerships

When we put unexpected teams in the same room, we fuel 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 a passionate team pushing the boundaries of science and technology to transform outcomes for people with cancer. You will work where empowered guides come together quickly to tackle complex problems, using real-time data, modern methodologies and decisive governance to move from signal to decision without delay. We bring unexpected teams together to spark bold ideas, value kindness alongside ambition, and connect individual contributions to a clear purpose: advancing therapies that change lives while advancing your leadership in global patient safety.

If you are ready to own the safety strategy behind groundbreaking cancer medicines and deliver rapid, patient-centered decisions with global impact, take the next step today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.