Senior Director of Preclinical Research, Ethicon, Inc.

Ethicon, Inc., a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Director of Preclinical Research, Ethicon, Inc. to be located in Cincinnati, OH or Raritan, New Jersey. Ethicon, a Johnson & Johnson company is currently $9 billion in Worldwide sales. Our Vision is to shape the future of surgery. Our purpose is to advance innovation in surgery, address the world’s most pressing healthcare issues and help our customers achieve better outcomes and impact more lives. The business is expected to experience solid growth over the next 5 to 7 years. Ethicon's key surgical/ interventional platforms are: Biosurgery, Wound Closure, Open and Minimally Invasive Stapling, Energy, Reflux Disease, Microwave Ablation Solutions, Advanced Imaging and Digital Solutions. Ethicon’s Senior Director Pre-Clinical Affairs within the Preclinical, Clinical and Medical Affairs (PCM) Team will lead the preclinical evidence generation necessary to ensure patient safety and competitive positioning of Ethicon’s surgical/ interventional products. This leader will work closely with cross functional partners across the different platforms at Ethicon, Inc, develop preclinical scientific staff, collaborate with internal and external partners, and actively support the Ethicon business by delivering a state-of-the-art preclinical study program. This leader will serve as a key member of the PCM leadership team. We challenge this leader to leverage her/his preclinical research and device expertise and collaborative partnering capabilities to define, guide and support the scientific vision and strategy for Ethicon’s surgical platforms, collaborating closely with the multi-functional evidence teams: Medical, Clinical, Preclinical and Health Economics, as well as the R&D project teams. This leader holds overall responsibility for Ethicon’s industry-leading preclinical evidence organization, focused on innovation and patient safety for all Ethicon platforms. The Sr. Director of Preclinical Research will: Oversee the development and implementation of robust preclinical plans and evidence-based strategies for Ethicon projects that ensure patient safety, minimize risk to product approvals and increase product adoption to our customers. Elevate the Preclinical team’s contribution in the innovation process across Ethicon platforms using deep preclinical expertise in surgical devices. Direct execution excellence and deliver Preclinical evidence to offer differentiated value to advance innovation in Ethicon. Develop the advanced modeling team within Ethicon. Develop strong relationships with Clinical, Medical affairs and the Office of the Chief Medical Officer to identify potential patient risks and use of products that can be evaluated in preclinical studies Work cross-functionally with Clinical, Medical affairs, HEMA and Commercial to identify and develop robust preclinical data packages and disseminate the results. Provide scientific input and rationale for highest potential projects in Ethicon to effectively direct and utilize resources. Direct staff to execute preclinical plans and deliver preclinical evidence against the new product development pipeline goals. Connect externally and engage strategically with regulators, customers, thought leaders, CROs and other external partners to anticipate industry trends and unmet needs, facilitate innovation, enhance product development and physician testing of Ethicon products in preclinical studies. Develop capability for preclinical affairs in Asia Pacific region. Prioritize, assign resources, and address lifecycle needs across all platforms as they arise, in close collaboration with cross-functional partners. Represent the Preclinical function at the Ethicon and R&D leadership team, as needed. Work with the Biocompatibility and Toxicology groups to execute product design evaluations and preclinical evidence strategies required for product approval, safety and product adoption. Identify appropriate animal and bench top models that may be used to drive product development and safety assessments. Talent Development: Develop and strengthen the preclinical talent pipeline. Will report into the Global Head of Preclinical, Clinical and Medical Affairs. Qualifications A minimum of a Doctorate degree (e.g., PhD, MD, DVM, or equivalent degree) in biosciences, medicine, bioengineering, or related field is required. A minimum of 10 years of managing a group comprised of senior scientific staff (Phd. DVM, MD) in a pharmaceutical and/or medical device industry is required. Track record of new product introduction and product life cycle management is required. Extensive knowledge of preclinical regulatory requirements for regulatory submissions for FDA and international agencies, like TUV and EU MDR, with proven track record of successful approvals of submissions to FDA and other international agencies is required. Extensive experience with interacting and communicating with (international) regulatory agencies around preclinical submission strategies and data is required. Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required. Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the transformation of a function is required. This position will be based in either Raritan or Cincinnati, OH and will require up to 35% domestic and international travel. Proven track record in delivering clinical research programs within surgical (device) research setting, from pre-clinical trial design to execution, including successful dissemination. Experiences/Capabilities/Competencies Must possess high emotional intelligence; excellent oral and written communication skills; excellent interpersonal skills for interactions with internal colleagues and external customers. Ability to lead, inspire and influence a team, functioning in a matrixed structure, through a period of change and in alignment with the strategic direction of the Ethicon PCM leadership. Self-reflective and aware of her/his own limitations, open to feedback and self-improvement. Commitment to building a culture of collaboration and trust with diverse colleagues that reflect the commitment of Johnson and Johnson to diversity, equity and inclusion. Demonstrated business acumen. A proven ability to execute and get results through leading others in complex technical organizations whilst leading by example. Demonstrated ability to build successful relationships and develop partnerships with key business partners and customers/investigators. A risk-taker who anticipates and mitigates risks or unintended circumstances. A team player in the leadership team of Global Medical, Clinical and Preclinical Affairs At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Primary Location United States-Ohio-Cincinnati-4545 Creek Road Other Locations North America-United States-New Jersey-Raritan Organization Ethicon Inc. (6045) Job Function R&D Requisition ID 2206022291W