Therapeutic Area Safety Head, Immunology

Janssen Research & Development, LLC, is recruiting for a Therapeutic Area (TA) Safety Head, Immunology to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at  www.janssen.com  and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Therapeutic Area (TA) Safety Head, Immunology, is responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSO) and Safety Analysis Scientist TA Lead (SAS TAL) within the Immunology Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM). The TA Safety Head (TASH) is charged with overseeing end to end medical safety strategy of both marketed products and products in clinical development within the assigned TA and determine the need for safety risk mitigation measures. The TASH 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 of assigned pharmaceutical products. In this role, the TASH will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of products in the TA 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 TASH maintains compliance with legal and regulatory requirements.

Responsibilities include but are not limited to the following:

• Shape the safety strategy and risk management for all J&J Pharmaceutical products during drug development and post-marketing within the assigned TA
• Partner closely and effectively with the Immunology TA, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) Pharma, the Qualified Person for Pharmacovigilance (QPPV) Pharma, other Pharmaceutical R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for products throughout the lifecycle
• 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.
• Provide oversight, medical expertise and leadership to the Immunology Medical Safety Officers (MSO), SAS TAL and their direct report Scientists for the end-to-end medical safety strategy of their assigned products
• Grow, attract, retain, and develop top talent, and build teams to ensure organizational effectiveness, transparency, and communication.
• 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 TA, both written and verbal
• Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements
• 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 TA Labeling Committee
• Coordinate safety topics within assigned TA that are presented to Medical Safety Council
• In collaboration with other TASHs and TALs, ensure consistency of medical safety-related processes across TAs 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 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