Job Title: Medical Director, Patient Safety Physician
GCL : F
Introduction to role:
Are you ready to set the clinical safety strategy that safeguards patients while accelerating transformative medicines? This role puts you at the center of benefit-risk decisions for high-impact therapies, guiding products from development through post-marketing with clarity, speed and scientific rigor.
You will lead the safety strategy for assigned programs, translating sophisticated data into crucial actions that shape labeling, risk minimization and regulatory outcomes. Working across functions and geographies, you will align guides around a transparent safety narrative and ensure that patient protection and business objectives move forward together. How will you use your clinical judgement and leadership to anticipate risk, advise pivotal decisions and help bring life-changing treatments to patients faster?
Accountabilities:
Safety Strategy and Governance: Own the clinical safety strategy for assigned products across late-stage development and post-marketing,
including defining identified and potential risks, proposing mitigation and minimization measures, setting safety go/no-go criteria, and shaping the risk component of benefit-risk assessments at project and governance forums.
Risk Management Planning: Review and endorse core Patient Risk Management Plans and provide medical expertise to safety specifications, pharmacovigilance plans and risk minimization activities across core, development and locally reviewed plans; ensure risk minimization strategies are implemented in product reference safety information.
Clinical Development Integration: Provide strategic clinical safety input to development planning; give to project-specific safety requirements; review and approve investigator brochures, protocols, informed consents and study reports; engage with external data supervising committees as appropriate.
Signal Detection and Evaluation: Lead or give to surveillance activities