Executive Director, Therapeutic Area Safety Head, Cardiopulmonary

Executive Director, Therapeutic Area Safety Head, Cardiopulmonary

Johnson & Johnson, is recruiting for an Executive Director, Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ; Titusville, NJ or Horsham, PA.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

The Therapeutic Area Safety Head, Johnson and Johnson Innovative Medicine (J&J IM), is responsible for the oversight of deliverables and the strategic direction of the Medical Safety Officers (MSO) and Safety Analysis Scientist (SAS) TA Lead within Cardiopulmonary (CP) Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM) in Global Medical Safety (GMS). 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 J&J IM 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 IM products during drug development and post-marketing within CP TA
• Partner closely and effectively with the TA, the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) J&J IM, the Qualified Person for Pharmacovigilance (QPPV) and other J&J IM 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 J&J IM for the implementation and compliance of post-marketing risk management commitments.
• Provide oversight, medical expertise and leadership to the TA 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.
• 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 J&J IM 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 of pharmaceutical medicines
• 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 where relevant

Education and Experience :

Required Technical Knowledge and Skills :

The anticipated base pay range for this position is $226,000 to $391,000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Additional information can be found via the following link :

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https : / / www.jnj.com / contact-us / careers or contact AskGS to be directed to your accommodation resource.