Product Safety Head (Sr Director) - Solid Tumors

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Product Safety Job Sub Function: Product Safety Risk Management Job Category: People Leader All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America Job Description: The Product Safety Head – Solid Tumors is responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSOs) and Safety Analysis Scientists leading Product safety strategy and risk management activities in Global Safety Strategy & Risk Management (GSSRM). The Product Safety Head is charged with overseeing end to end medical safety strategy of both marketed and developmental phase activities of Product and any other assigned products and determine the need for safety risk mitigation measures. The Product Safety Head will also maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices, and implementing new approaches to support the scientific evaluation of the safety risk profile Product. In this role, the Product Safety Head will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products in the Product portfolio, preparation of aggregate safety reports and responses to Health Authorities (HA) and, when appropriate, communication of potential and known risks to Senior Management, HAs, Prescribers and/or Patients. The Global Safety Head - Product maintains compliance with legal and regulatory requirements. Roles and responsibilities: Shape the safety strategy and risk management for all assigned J&J Pharmaceutical products during drug development and post-marketing Partner closely and effectively with the TASH, the Head of Global Safety Strategy and Risk Minimization (GSSRM), the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) JJ IM, the Qualified Person for Pharmacovigilance (QPPV) JJ IM, other JJ IM R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle Provide oversight, medical expertise and leadership to the Product Medical Safety Officers (MSO) and the safety analysis scientists for the end to end medical safety strategy of their assigned products Provide input into key regulatory documents (e.g. Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERS/PSURs, REMS/RMPs) and serve as the designated GMS leader and signatory on the program Labeling Committees Connect with respective colleagues in the Clinical TA, Medical Affairs, Global Regulatory Affairs and the QPPV Pharma for the implementation and compliance of post-marketing risk management commitments. In collaboration with GSSRM TASHs and TALs, ensure consistency of medical safety-related processes to ensure cohesive and coordinated approaches to best practices of clinical and post-marketing safety, working with QPPV Pharma and other GMS functions to implement needed process improvements and maximize operational efficiencies Serve as the Safety Representative on