Associate Director, Clinical Research- Knee

Job description

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: People Leader All Job Posting Locations: Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America Job Description: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech DePuy Synthes is recruiting for an Associated Director, Clinical Research, located in Warsaw IN, or alternately in West Chester PA, Raynham MA, or Palm Beach Gardens FL. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Job OverviewThe Associate Director, Clinical Research is a member of the global Medical & Scientific Affairs team responsible for supporting evidence generation and clinical study execution for DePuy Synthes’ orthopedic medical device portfolio (Knee Reconstruction). The role advances global evidence strategies by identifying evidence gaps and priorities in the Knee Reconstruction portfolio, translating them into actionable recommendations, and coordinating delivery. The successful candidate will bring medical device clinical research leadership experience—preferably in orthopedics, joint replacement, or surgical products—and will work closely with clinical sites, registries, and cross-functional partners to generate high-quality evidence that supports patient outcomes, product innovation, regulatory requirements, and business needs. Key ResponsibilitiesLead a team of clinical research professionals to develop and deliver global evidence-generation and evidence-dissemination strategies for the Knee Reconstruction platform, supporting new product development and life-cycle management. Partner with Clinical Operations and Biostatistics and Data Management teams to deliver assigned clinical programs on time, within budget, and in compliance with applicable regulations and internal procedures; oversee study milestones, enrollment projections, risks, and the quality of deliverables. Partner with regional clinical leaders and Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Market Access, R&D, and other cross-functional stakeholders to identify evidence gaps and integrate clinical practice, customer, regulatory, and reimbursement needs into aligned global evidence priorities and plans. Lead clinical research scientists in designing clinical studies to address prioritized evidence gaps and new product development and life-cycle management needs; partner with Clinical Operations on feasibility, site selection, study start-up, execution, and close-out. Lead the interpretation and dissemination of clinical evidence through clinical study reports, Post Market Clinical Follow Up plans & reports, abstracts, and manuscripts; partner with internal stakeholders to ensure accurate use of evidence in value briefs and technical summaries supporting market access and reimbursement. Lead clinical scientific discussions with regulatory agencies and notified bodies to support global clinical and regulatory strategies, proposed clinical investigations, marketing authorizations, and line extensions; provide clinical scientific support during regulatory inspections. Build and maintain relationships with key opinion leaders, orthopedic investigators, clinical sites, research networks, ethics committees, professional societies, and associations to advance clinical research collaborations and inform relevant evidence policies. Develop collaborations with national and international joint replacement and medical device registries to support data requests, analyses, research partnerships, and interpretation of real-world evidence that informs global evidence strategies. Ensure clinical programs comply with Good Clinical Practice, relevant country regulatory and ethics requirements, and internal quality procedures, with oversight of informed consent, safety reporting, essential documentation, and data integrity. Provide clear program status reporting, evidence-based decision support, and coordination across regions and time zones; escalate business issues, opportunities, and risks to the appropriate management level. Support audit and inspection readiness through complete study documentation, coordinated responses, interview preparation, and timely completion of corrective and preventive actions for study-related findings. Follow applicable Company Health, Safety and Environmental guidelines; ensure team members follow these guidelines and have the resources needed to do so. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed QualificationsEducation Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline (required) Advanced degree (Master’s or PhD) in a scientific or clinical discipline (preferred) Experience and Skills Required: Minimum of 8 years of progressive clinical research or clinical operations experience, including leadership / management role within Clinical Research. A minimum of 2 years people management experience is required for this role Demonstrated experience managing medical device clinical studies across multiple phases of execution Understanding and application of Good Clinical Practices Understanding and application of regulations and standards applied in clinical areas/regions is required Demonstrated professional and ethical leadership in a matrixed organization Experience supporting global regulatory submissions, post-market clinical fo