- Entry level
- No Education
- Salary to negotiate
Ethicon Endosurgery of Johnson & Johnson, is recruiting for an Manager, Preclinical 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.
The Manager, Preclinical 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 in this role will be responsible for allocating resources and ensuring staff deliverables meet new product development and life cycle management project timelines. The individual will manage preclinical senior scientist/associate scientist level staff responsible for developing and executing on project goals within the platform.
Develop preclinical strategy and ex vivo and in vivo models, design studies, serve as hands-on preclinical surgeon or study sponsor as needed, write final reports in compliance with US and International regulatory requirements.
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.
Partners with the R&D leaders to understand future project’s needs; including model development for testing design feasibility and conducting formal preclinical verification & validation testing. Partners with senior members of the preclinical team and preclinical management and plans preclinical milestones to align with business needs.
Review and approve scientific strategies (Preclinical Strategy, EGS, and TPPs) for each project within the platform.
Manage senior scientist/associate scientist level preclinical staff and study coordinators (contractors) to deliver robust preclinical strategies and ensure timely execution of plans to meet project and platform goals.
Partner with senior scientific staff to provide technical oversight and input into model development and study protocols in the advanced modelling group. Develop and implement lab procedures and processes that drive efficiency and robust quality and high scientific value in the functionality and advanced modelling group
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.
Under the guidance of the Preclinical Senior Director, 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.
Work cross-functionally with clinical, medical affairs, HEMA and commercial to identify and develop robust preclinical data packages and disseminate the results.
Draft/Review the Preclinical (Functionality/Pharmacology) sections of regulatory submissions, investigator brochures, etc., as well as addressing subsequent regulatory
About the company
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