Depuy Orthopaedics, Inc., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Clinical Research, Digital Surgery Platform, to be located in Cincinnati, Ohio and may require up to 25% domestic and international travel.
Johnson and Johnson Medical Device Companies
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
Ethicon’s long-term vision is to use digital technology as part of a holistic approach to surgery across the episode of care to enhance surgical efficiency, promote better clinical outcomes and increase patient satisfaction. This unique position will provide scientific leadership for Ethicon’s Digital Surgery Platform, collaborating closely with the multi-functional evidence teams: Medical, Clinical, Pre-clinical and Health Economics and Market Access.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Responsibilities include:
Lead team of clinical research professionals to develop and deliver appropriate global evidence generation strategies (Pre-and Post-Market approval- studies, Investigator Initiated, Real World Evidence) aligned to the needs of the R&D, Regulatory, Professional Education and Commercial Digital Surgery platform
- Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the clinical evidence generation strategies;
- Contribute and support the design of appropriate clinical trials to meet the premarket and post market needs;
- Strengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutions for Digital Surgery platform
- Identify areas of highest impact for the Digital Surgery portfolio, create and implement solutions that significantly impact ROI, and communicate impact across the organization
- Develop network with key surgeons in EU and US to assist in execution of Digital Surgery clinical trials for registration in both regions
- Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including CSRs, abstracts, manuscripts, etc.
- Support 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;
- Provide scientific, technical, and strategic assessment and/or oversight on New Business Development opportunities, and support acquisition of innovative products/devices that will position our company for future growth and success
- Demonstrate the ability to influence, shape and lead teams
- Develop talent to provide strategic and scientific clinical research capability, including responsibility for professional development of direct reports
- Have experience in effective management of project budget processes;
- Through transparent leadership, be a key leader in developing a high-performing team with a global culture;
- Build successful relationships internally and develop partnerships with key business partners and customers/investigators
- A minimum of a Bachelor’s degree in Biological Science or a related discipline is required. An advanced degree (Master’s or PhD) is preferred
- A minimum of 8 years of related scientific / technical experience, including leadership / management role within Clinical Research is required
- A minimum of 2 years of people management-related experience is required for this role
- Experience working in Digital Surgery/Robotics Area is strongly preferred
- Expertise in 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
- Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred
- Ability to lead a team of clinical scientists to provide strategic and scientific clinical research input across NPD and LCM projects is preferred
- Proven track record of contributing to clinical programs within a clinical or surgical research setting, on time, within budget and in compliance to SOPs and regulations is required
- This position will be located in Cincinnati, Ohio and may require up to 25% domestic and international travel
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
Medical Device Business Services, Inc (6029)
Clinical Research non-MD