Johnson & Johnson Careers
Director, Franchise Clinical Affairs
Requisition ID: 8946180807
DePuy Synthes, a Johnson & Johnson Family Company, is recruiting for a Director, Franchise Clinical Affairs. This position will be located in West Chester, PA, Raynham, MA, Warsaw, IN, Somerville, NJ, or Cincinnati, OH.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director, Franchise Clinical Affairs plans, directs, and manages the activities of the Clinical Research department such as designing, planning, developing and monitoring of clinical trial projects. Has an understanding of the clinical implications of the EU Medical Device Regulations (MDR). This position complies with the department, company and regulatory standards and procedures. At this level, the position has more impact on the business results and typically, responsibility for managing a group of professionals.
- This leader will be accountable to lead a team of clinical research professionals to develop evidence generation strategies for DePuy Synthes Trauma, CMF and Biomaterials (TCB), and, through transparent leadership, develop a high -performing team with a global culture
- Reports to the VP, Integrated Medical, Clinical, pre-Clinical Leader, Trauma, CMF and Biomaterials;
- Accountable for all Clinical R&D activities for TCB:
- Serving as the Clinical representative on the platform governance / innovation committees, provide critical and technical expertise in portfolio prioritization;
- Provide critical technical and strategic expertise in the assessment of NBD projects and opportunities identified through the Innovation Centers, including potential investment and acquisition opportunities, to shape business strategy;
- Build and develop talent to provide deep strategic and scientific clinical research capability across assigned platforms;
- Lead team of clinical research professionals to develop and deliver appropriate Global Evidence Generation and Dissemination Strategies (EGS / EDS) to support New Product Development and Life-Cycle Management within the assigned platforms, with collaborative relationships with all relevant cross-functional partners (e.g. Global and Regional Marketing, Medical Affairs, Regulatory Affairs, G-HEMA/EBM, R&D, etc), ensuring cross- functional alignment;
- Accountable for overall delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);
- Ensure input and strong alignment from key regional Clinical leads and other strategically important countries/regions in the development of Global EGS / EDS;
- Lead team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs;
- Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, etc.
- Lead clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections and MDR compliance;
- Accountable for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc.;
- Partner with EBM/G-HEMA and Medical Affairs to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
- A Bachelor’s Degree with a minimum of 12 years’ experience in years related scientific / technical experience, including leadership / management role within Clinical Research is required. A Master’s Degree with a minimum of 10 years of the above experience or a PhD with a minimum of 8 years of the above experience is preferred
- A minimum of 5 years’ experience performing full management of investigator sponsored studies and acts as liaison with study sites is required
- At least 5 years of experience managing individuals at the PhD level is preferred
- Thorough understanding of Clinical Research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required
- Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and i n compliance to SOPs and regulations is required
- Experience implementing clinical study parameters, deliverables, policy compliance and resource needs is required
- Experience evaluating and documenting study results in preparation for new device application to the regulatory agencies is required
- Existing Clinical SME in the Medical Device Regulation (MDR) Program is strongly preferred
- This position will be located in West Chester, PA, Raynham, MA, Warsaw, IN, Somerville, NJ, or Cincinnati, OH and may require up to 25% domestic and international travel
United States-Pennsylvania-West Chester
North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Somerville
DePuySynthes Products Inc (6149)
Clinical Research non-MD