Sr. Director, Senior Safety Officer- Johnson & Johnson Enterprise Innovation

Johnson & Johnson, is recruiting for a Senior Safety Officer - Johnson & Johnson Enterprise Innovation (JJEI) to be located in New Brunswick, NJ, Titusville, NJ; Raritan, NJ; Horsham, PA or other Johnson & Johnson locations within the United States.

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 https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes single case signal detection activities for selected products.

The Senior Safety Officer (SSO) has responsibility for implementing the safety strategy and risk management efforts of the Office of the Chief Medical Officer (OCMO) for J&J Enterprise Innovation (JJEI), and Interventional Oncology (INTO). With a particular focus on INTO, and other cross-enterprise efforts, the SSO will provide strategic thought leadership on a broad range of safety topics including benefit-risk insights & assessments, due diligence, new product development including clinical development programs, signal surveillance and risk management. The SSO will also provide medical safety insights and support to other JJEI functions as appropriate.

The SSO is a leader of the Safety Management Teams (SMTs) and / or manager or Medical Safety Officers (MSOs) who lead SMTs, and will work with other JJEI, and INTO members to impact patient/consumer outcomes through science and data driven, and ethics and values-based decision making. S/he will drive excellence in risk management, operational excellence, focus on continuous improvement and developing trusting partnerships internally (e.g. R&D, Quality, Regulatory, Commercial, Legal, Medical Affairs) and externally (e.g. regulators, professional organizations, investors, advocacy groups) to inform portfolio decisions and shape best practices for the benefit of patients/consumers and HCPs. The SSO will work collaboratively with key stakeholders across JJEI, and INTO to identify, evaluate, understand, communicate and enhance the safety profile of the JJEI, and INTO portfolio. In this role, the SSO will help ensure proactive and timely assessments of safety data, understanding of the emerging and known safety profiles of the products and solutions within JJEI, and INTO, preparation of aggregate safety reports and responses to Health Authorities (HA) and when appropriate, and communication of potential and known risks, to Senior Management, HAs, Prescribers and/or Patients.

In compliance with legal and regulatory requirements, the SSO will also contribute to and supervise, when appropriate, the design and implementation of processes to manage risk associated with the use of JJEI, and INTO products and solutions. This work & collaboration will span across MedTech and Pharmaceuticals. S/he will ensure the appropriate safety structure, systems and processes are implemented to support JJEI, and INTO.

The SSO is responsible for reviewing, assessing, and evaluating safety and efficacy data from all sources throughout product development through post marketing (as appropriate), to identify changes in a products' benefit-risk profile. Based on these evaluations, the SSO will partner with cross functional teams, through a collaborative and consensus driven process, to make decisions on benefit-risk in a timely manner. Urgent benefit-risk issues that may pose an immediate threat to patient safety or may substantially change the benefit/risk profile of the product are escalated to the Medical Safety Council for immediate advice and decision making. The SSO is responsible for implementing the vision of excellence and culture of learning, to develop new scientific capabilities and optimize operations.

• Exceptional medical safety judgement applicable to a broad range of safety related activities (e.g. signal detection, medical safety review, health hazard evaluations, development of risk mitigation strategies)

• Handle scrutiny and pressure to establish deep credibility as experienced and thoughtful medical safety leader and organizational change agent

• Determines distinctive medical safety insights to provide substantial thought leadership to business partners.

• Provides strategic guidance on frameworks that determine escalation of safety insights, medical evaluation, safety data management, cross-functional activities, Medical Affairs support, etc.

• Sets guidelines for determining accuracy of SMT decisions and coordinates strategy to share insights across partners and product lifecycle.

• Serve as a role model for developing trusting relationships and collaborative work environment that is diverse and inclusive.

• Demonstrate and inspire behaviors that reinforce the J&J Credo.

• Foster a culture that promotes and supports innovation Create culture of accountability and continuous improvement.

Medical Safety Oversight:

• Implement fit for purpose safety governance, oversight and support across the JJEI and INTO teams

• Working closely with INTO, R&D and Medical Affairs to ensure that safety standards are maintained along the entire program & clinical development continuum (as appropriate).

• Guiding safety evaluations across the product portfolio, ensure safety obligations are met, and drive the highest standards of compliance.

• Member of multiple leadership teams, governance forums and committees

• Lead or Participant in: Safety Management Teams, also liaise with relevant cross sector SMTs, JJEI Medical Safety Council, JJEI Development Advisory Committee, and Development Teams for specific JJEI assets.

• Participate in JJEI and cross sector First in Human Committee

• Key communicator to cross-functional partners of relevant medical safety information and decisions

• Provides guidance and sets direction for refining policies and procedures for maintaining and enhancing medical safety compliance and operational excellence with goal of continuous improvement.

• 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 support for Business Development efforts as they relate to safety during identification, evaluation and licensing of new products.

• Implement a vision for excellence, a forward-thinking strategy, and pursue implementation of the new medical safety organization/process for JJEI, and INTO. Communicate this across the JJEI, and INTO and ensure each team member truly understands their part in taking the function to the next level.

• Provides leadership, expertise and consultation to external stakeholders (example: regulatory, governmental, NGOs, professional organizations) on company issues. Develops and orchestrates programs that enhance the safe use of J&J products and build trust with patients/consumers and healthcare providers

• Coordinate safety topics within assigned TA that are presented to Medical Safety Council

• Provide input into key regulatory documents (e.g. Ad hoc reports, Health Hazard Evaluations, Clinical Overviews) and be a signatory when appropriate.