Principal Preclinical Scientist

Job description

Job Description

Requisition ID: 1751180530

Ethicon Endosurgery of Johnson & Johnson, is recruiting for a Principal Preclinical Scientist to be located in 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 27 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 Principal Preclinical Scientist will serve as a key scientific contributor for the development and execution of strategies for preclinical evidence necessary to competitively position a project's product for domestic and international regulatory and clinical acceptance. The individual will independently design, execute, analyze and interpret preclinical studies to understand the safety and efficacy of product concepts. The individual will work closely with cross functional groups within and external to the COE to meet project objectives.

Principal Duties and Responsibilities

·  Serve as core team member on project teams.
·  Serves as a subject matter expert to support preclinical due diligence
·  Provide preclinical scientific input on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle.
·  Responsible for partnering and contributing to the Target Product Profile (TPP), evidence generation strategies, and for the project per NPD stage gate process.
·  Responsible for creating the Preclinical strategy and plan, and overseeing study execution per project timelines
·  Attend all core team meetings and serves as a single point of contact for communication between the project team and preclinical operations.
·  Assess, communicate and manage the risks associated to the preclinical evaluation of product concept for projects to ensure success.
·  Communicating progress and milestone status to preclinical leadership, R&D partners and others.
·  Organize multi-disciplinary team and engage necessary disciplines (Advanced Modelling, Surgery, Preclinical Ops) to address project goals and objectives.
·  Partners with Preclinical Ops leader to identify and incorporate chemical safety requirements into the preclinical strategy and plan.
·  Works cross functionally with Medical Affairs, Safety, Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects.
·  Collaborate with industrial design and human factors group to create robust usability evaluations. Participate labs, as needed, to develop understanding of customer unmet needs, potential misuse situations and help interpret customer feedback to R&D team.
·  Responsible for planning preclinical animal studies as needed for Design Validation
·  Surveys the literature to identify and compare competitive product performance and safety risks.
·  Responsible for the development of and modifications to preclinical models to address project needs.
·  Serves as the preclinical subject matter expert for projects at First in Human Committee consultations and reviews.
·  Responsible for the design of preclinical functionality and safety animal studies.
·  Provides input and reviews for study protocols and reports from internal and external preclinical studies.
·  Works closely with Preclinical Ops to ensure execution of study protocol at internal vivarium.
·  Communicate internal animal study requests and requirements to Preclinical Ops operations group to ensure appropriate resourcing and scheduling.
·  Identify external labs (academic, CRO), as needed, to execute preclinical animal studies. Communicates to Preclinical Ops to initiate contract and audits, if necessary
·  Partner with Preclinical Ops to ensure external facilities meet J&J standards for animal use and to generate contracts for vendors.

Desired profile

Qualifications

·  A minimum of a Doctorate degree in biological sciences, biomedical engineering, veterinary medicine is required
·  A minimum of 8 years of experience in a preclinical setting is required
·  A minimum of 2 years working in a medical device or pharmaceutical setting is required
·  Knowledge of medical device regulations, regulatory/notified body requirements is preferred
·  Demonstrated ability to work cross functionally and influence a program direction is required
·  Ability to clearly document and communicate plans and results is required
·  The ability to lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility is required
·  This position will be located in Cincinnati and may require up to 10% travel

Primary Location
United States-Ohio-Cincinnati-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
R&D
Requisition ID
1751180530