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 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 clear 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 including medical review of individual cases, signal detection and evaluation; identify and use appropriate data sources; collaborate with external providers; deliver clear, fit-for-purpose safety evaluations and chip in to SIRC activities and collaborator discussions, including with Patient Safety leadership and QPPV/Deputy QPPV. Labeling and Regulatory Interactions: Provide medical input to labeling updates and responses to regulatory requests, including strategic input for local label deviations; in consultation with PS scientists and clinical teams, prepare Developmental Core Safety Information for development products. Regulatory Reports and Submissions: Provide medical input and review of periodic reports (PBRERs, PSURs, DSURs) and renewal documentation; lead Patient Safety contributions to global submissions (NDA, BLA, MAA) for products, formulations or indications. Cross-Functional Leadership: Represent Patient Safety on clinical and project teams; facilitate Safety Management or Safety Review Teams; give to ad hoc teams addressing urgent safety issues; present safety information at investigator and commercial meetings as needed. External Engagement and Governance: Give to PS components of Safety Agreements; advise on licensing agreements; participate in external meetings with regulators, partners and opinion leaders; support due diligence and, when appropriate, product liability litigation. Quality, Audit and Improvement: Maintain inspection readiness; raise issues promptly and appropriately; lead or participate in process improvement initiatives; propose methodological and process innovations; mentor and train junior team members in signal evaluation, risk management and safety reporting. Collaboration and Culture: Work seamlessly with preclinical safety, informatics, safety science and other guides to ensure robust evaluation of safety data; understand and support the pharmacovigilance system and the role of the QPPV; collaborate effectively across functions, cultures and external providers. Essential Skills/Experience: Medical degree (eg MD, MBBS) 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 Up to 11-13 years of Patient Safety experience (with clear evidence of delivery) Total 16 years of experience A detailed 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 Skills and Capabilities: Dedication to Customers and Integrity (represents and shapes customer perspectives) Strategic Leadership (identifies untapped opportunities) Acts Critically (create clarity for others to act conclusively) Drives Accountability (creates cross-boundary accountability) Works Collaboratively (establishes shared purpose across boundaries) Develops People and Organisation (invests in long-term development of others) Technical (Professional level): Drug Development Experience and Application of Disease and TA knowledge Integrative thinking Excellence in pharmacovigilance Patient Benefit risk assessment Conceptual thinking (associates seemingly unrelated information, analyses situations, takes long term view) Influencing (presents positive image, demonstrates flexibility, effectively facilitates communication applies negotiation strategies and tactics, to reach conclusion) Initiative (acts proactively, proposes improvements where appropriate) Innovation (stays current on emerging trends and new practices within relevant areas) Business relationship management (demonstrates good knowledge of relevant specialist area, develo