Product Safety Head (Sr Director) - Solid Tumors

About this role

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 the Sponsor Committee for the Independent Data Monitoring Committee • Provide input on licensing and acquisition pharmaceutical candidates • Support TASH and GSSRM Head in proactively managing of the annual budget and planned resource allocation of individuals to meet the portfolio objectives throughout the year. • Support regulatory inspection readiness, inspections, and CAPAs • Develop or revise SOPs as Business Process Owner or functional stakeholder • Create a workforce that is reflective of global diversity by promoting diversity, equity, and inclusion in the organization and by hiring and retaining diverse talent and fostering a community that supports inclusivity • Act ethically and responsibly to ensure patient safety is paramount • Provide leadership in regulatory authority interactions regarding safety and risk management for the CTP, both written and verbal • Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements • Grow, attract, retain, and develop top talent, and build teams to ensure organizational effectiveness, transparency, and communication

Education and Experience: • Physician (MD or equivalent) with 10 or more years of substantial Pharmaceutical Industry experience; clinical experience highly preferred. • Management experience in supervising a group of employees; demonstrated strong CREDO values; proven leadership skills; ability to thrive in a global, matrix environment. • Significant skills in clinical medicine and pharmacovigilance, including experience in post-marketing safety assessment • Knowledge of oncology products and the associated PV guidelines and global regulatory framework • Oncology therapeutic area experience is preferred • Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of risks and benefits, and safety assessment of compounds both on the market and in develop

Similar jobs

• Medical Safety Officer - Solid Tumors Oncology — Johnson & Johnson · Horsham, Pennsylvania, United States | Raritan, New Jersey, United States | Titusville, New Jersey, United States
• Senior Director, Global Clinical Safety — Edwards Lifesciences · California – Irvine, United States
• Principal Scientist, Safety — Neurocrine · US CA San Diego
• Senior Product Safety and Compliance Engineer- Medical Devices — Sharkninjaoperatingllc · Needham, MA, United States
• Senior Product Manager, Safety — Discord · San Francisco Bay Area
• Senior Product Safety Architect II — Maymobility · Ann Arbor, MI
• Scientific Director - Medical Communications (Solid Tumor Oncology) — Lockwood · Remote
• Senior Product Safety Engineer II — Maymobility · Ann Arbor, MI