J&J Family of Companies Director Safety Surveillance & Risk Management (SSM) in Fort Washington, Pennsylvania
Johnson & Johnson Consumer Products Company is looking to hire a Director Safety Surveillance and Risk Management (SSRM) based either in Skillman, NJ or Fort Washington, PA.
The Director Safety Surveillance and Risk Management (SSRM) responsible for Development Programs within the Office of Consumer Medical Safety (OCMS) will work with R&D and cross-functional partners to imbed safety strategies into end-to-end J&J Consumer Inc (JJCI) development processes and programs with the goal of helping patients and consumers realize maximal benefit free from avoidable harm with the use of our medicines, cosmetics, devices and other products.
As a key member of multi-disciplinary teams, you will work closely with other functional experts to progress research projects. This leader will work collaboratively with R&D, quality and others to enhance current development processes and support key safety governance forums (e.g. First in Human Committee, Development Committee). The director will be expected to maximize efficiency and effectiveness by aligning safety-related activities within key and high priority development programs around common processes, systems, and practices, and implement new approaches to support the scientific evaluation of the safety profile of JJCI products in development. She/he will support safety stronghold team leaders and teams in developing, implementing and overseeing safety strategies covering the full range of development programs (pre-clinical, Phase1-Phase4).
The director will be accountable to ensure appropriate safety strategies are considered and implemented as part of clinical development: study design, protocol development and the conduct of clinical trials and that safety findings are appropriately evaluated, interpreted and reported. She/he will oversee the timely investigation and resolution of safety issues related to development programs and provide input into safety portions of regulatory documents (e.g. INDs, IBs, CTAs, NDAs).
The candidate will be required to build relationships and establish partnerships with internal and external scientific experts and industry associations and coalitions. He/she helps ensure proactive and timely assessments of safety data from development programs and helps to translate and present complex safety information to individuals and teams with varying degrees of scientific acumen and therapeutic area background.
The director will:
Work collaboratively with key stakeholders across many functions and will report to the Chief Safety Officer for JJCI
Influence key decision-makers, manage external partners/vendors, provide critical insights through thought leadership, and develop superior talent and people are critical factors for success in this role
Work with R&D and cross-functional partners to imbed safety strategies into end-to-end J&J Consumer Inc (JJCI) development processes and programs with the goal of helping patients and consumers realize maximal benefit free from avoidable harm with the use of our medicines, cosmetics, devices and other products
Manage and effectively influence safety decisions with internal and joint internal/external research partners with new innovations and marketed products across the entire cycle of clinical development including: study design, placement, monitoring, analysis, regulatory reporting, and publication
Provide strategic safety oversight for key and high priority development programs involving medicinal, cosmetic, devices or other consumer healthcare products across key major therapeutic areas including baby, beauty, oral health, topical health and wound care, women’s health, skin and hair care and a wide range of over-the-counter (OTC) medicines
Partner closely and effectively with portfolio stronghold leads across the Consumer sector, (including R&D, Medical Affairs, Quality and Regulatory), in addition to within the Office of Consumer Medical Safety (OCMS), to assess, guide, and communicate safety concerns and risk management for products in development
Provide input on licensing and acquisition candidates as needed, especially as it relates to development work
Promote sharing of knowledge between safety staff within the OCMS and facilitate the expansion of individual responsibilities and professional development
Work collaboratively with OCMS team members (e.g. global and regional medical safety officers, benefit risk & pharmacovigilance physicians, safety scientists), R&D, quality and others to enhance current development processes and support key safety governance forums (e.g. First in Human Committee, Development Committee)
Develop an external key opinion leader network and relationships with industry associations and patient advocacy groups to bring scientific, patient and medical expert insight to development programs
Provide leadership in regulatory authority interactions regarding safety and risk management for the JJCI Portfolio, both written and verbal
Ensure compliance of, and when appropriate contribute to design and implementation of, safety activities and processes with global legislation and regulatory requirements
Physician (MD) with postgraduate training and direct patient management/care experience with additional education, research or industry experience in relevant therapeutic areas required
Minimum of 10 years of industry experience working within R&D, preferably with both Rx and Consumer experience including expertise in the area of OTC medicinal drug development required
Track record of success managing medical safety topics, designing and executing clinical development programs, and using science-based strategies to successful influence external stakeholders including regulatory authorities for the benefit of patients and consumers required
Hands-on experience in global clinical trial conduct and operations and demonstrated ability to deliver clinical studies on time and on budget. Possess detailed knowledge of GCP and other regulations governing clinical studies required
Broad understanding of global safety regulations and regulatory requirements required
Clear track record of effective direct and indirect people management, including growing and developing talent to achieve results preferred
Track record of adherence to and enhancing quality and compliance and designing/leading/successfully implementing process improvement activities. Referenceable experience leading global cross-functional teams through change.
Excellent communication skills, both written and verbal
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Skillman-199 Grandview Road
North America-United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)
Drug & Product Safety Science
J&J Family of Companies
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