Associate Director, Preclinical Research
Ethicon Endosurgery of Johnson & Johnson,is recruiting for an Associate Director, Preclinical Research to be located in Somerville, NJ or Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic wound repair devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director, Preclinical Research in Ethicon will lead the development of strategies for preclinical evidence necessary to competitively position platforms' products for domestic and international regulatory and clinical acceptance. This individual will serve as the preclinical leader on integrated platform teams to work closely with other functions within the platform to develop robust strategies to meet platform business goals. The individual will manage preclinical staff responsible for developing and executing on project goals within the platform.
Principal Duties and Responsibilities
- Elevate the Preclinical contribution in the evaluation of product safety and innovation process across platforms using deep preclinical expertise.
- Contribute to the platform leadership team through preclinical input to business strategies that minimize risk to product approvals and patient safety and increase product adoption to our customers.
- Review and approve scientific strategies (Preclinical Strategy, EGS, and TPPs) for each project within the platform.
- Manage preclinical scientists and study coordinators (contractors) to deliver robust preclinical strategies and ensure timely execution of plans to meet project and platform goals.
- Attends all platform team leaders meeting.
- Knowledgeable of the vision, priorities, and issues of each platform
- Provide in-depth technical knowledge of the platform being supported and line of sight across platforms on common issues.
- Prioritize preclinical resources within the platform portfolio to ensure timely delivery of data and/or reports.
- Track all project deliverables for the platform and provide metrics on preclinical platform performance to goals and objectives.
- Provide preclinical input for the Design Requirements Matrix and the Evidence Generation Strategy to projects within platforms.
- Develop platform preclinical business plan including FTEs and operating costs to meet platform objectives and review with Preclinical Franchise leadership.
- Work cross-functionally with clinical, medical affairs, HEMA and commercial to identify and develop robust preclinical data packages and disseminate the results.
- Connect externally and engage strategically with, regulators, customers, thought leaders, academia, CROs and other external partners to anticipate industry trends and unmet needs, facilitate innovation, enhance product development and physician testing of platform products in preclinical studies.
- Draft/Review the Preclinical (Functionality/Pharmacology) sections of regulatory submissions, investigator brochures, etc., as well as addressing subsequent regulatory authority questions/defending data and results.
- Partner with preclinical operations group to identify resources to provide input to preclinical evidence strategies, as needed.
- Partner with preclinical operations and advanced modelling groups to identify resource and model needs, and to prioritize to platform goals to ensure execution of preclinical studies.
- Serve as Preclinical representative at First in Human Committee Triage Reviews of platform portfolio.
- A minimum of a Master's degree in biological sciences, biomedical engineering, or veterinary medicine and a minimum 10 years of preclinical experience in a medical device, pharmaceutical or academic setting is required. A Doctorate and a minimum of 7 years' experience is preferred
- A minimum of 5 years of managerial experience and demonstrated strong leadership skills is required
- Experience working in a GOP setting is highly preferred
- Product development experience is preferred
- Knowledge of medical device regulations, regulatory/notified body requirements is required
- Demonstrated ability to work cross functionally and influence a program direction is required
- Ability to clearly document and communicate plans and results is required
- Lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility is required
- Business acumen and experience, including skills in budgeting, resource management, and staff development is required
North America-United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD
Meet Some of Johnson & Johnson's Employees
Business Operations Lead JLABS Houston, Johnson & Johnson Innovation
Diana oversees JLABS Houston site operations, supporting various areas of business including compliance, operating systems, workflows and relationship management.
Back to top