Preclinical Study Director (Scientist)

Job Description

Ethicon Inc, is recruiting for a Scientist in Preclinical Operations, located in Cincinnati, Ohio. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.Our Scientists are the Preclinical Study Directors that lead all phases of preclinical studies (spanning from: Discovery, Development including studies to support regulatory clearance, and Evidence to drive market adoption) and ensure that study integrity meets the highest standards of biomedical research and development. Additionally, as a you will be performing product evaluations involving animate, inanimate, and cadaveric models. These studies include surgical support as an evaluator during research, development of medical devices. Responsibilities include:

• Scientists partner with Preclinical Project Lead to plan and develop protocols for GLP and non-GLP studies.
• As a Scientist in Preclinical Operations, you will act as a Study Director and be accountable for study execution for assigned studies and ensure the data is accurately recorded and verified.
• Complete training and periodic re-training to quality policies and procedures in area of responsibility within allowed time-period and then demonstrate an understanding through daily execution of studies.
• Promote a safe work environment to all associates by following company safety precautions in our laboratory work place.
• Facilitate support for the conduct, monitoring and reporting, preclinical studies within the facility. This responsibility will include partnering with Project Leaders and Contributing Scientists to ensure the best outcome.
• Serves as the single point of contact with the project leader to communicate timelines, issues and milestones regarding study conduct.
• You will partner closely with contracted staff (Research Assistants and Surgical Vet Technicians) assigned to studies. This will include pre-study meetings to train the staff to the protocol.
• Responsible for Identifying circumstances that may affect study quality and integrity are documented and corrective action taken
• Oversee the collection of study data and preparing data for analysis.

Qualifications

• Associates/Bachelor’s / Master’s degree in applicable field is required.
• Minimum 10 years of experience for associate degree / or equivalent is required.
• Minimum 4 years of experience for bachelor’s degree is required.
• Minimum 2 years of experience for master’s degree is required.
• Technical knowledge of medical device technologies in several platforms, such as Laparoscopy, Energy, Endo-mechanical, Wound Closure, or Orthopedics is preferred.
• Knowledge of the requirements of in vivo and ex-vivo preclinical study conduct is required.
• At least 4 years acting as a GLP Study Director is preferred.
• Knowledge of preclinical regulatory requirements for FDA, TUV, and other international agencies is preferred.
• A proven ability to engage and develop relationships with Research & Development Project Leaders to facilitate study execution is required.
• The ability to multi-task and organize multiple studies are required.
• Excellent communication skills – written/oral/listening is required.
• You will need in-depth knowledge of animal and human anatomy and physiology is required.
• Be able to use independent decision-making skills using analytical problem-solving as appropriate and communicate your plans and results are required.
• Use of influencing and negotiating skills to articulate a scientific basis for decisions to project team partners is required.
• You may perform surgical procedures which require standing or sitting for extended periods of time (including ability to stand in one place for up to 4 hours and work up to 8 hours without sitting) and you may lift up to 70 lbs. occasionally are required.

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
Primary Location
United States-Ohio-Cincinnati-
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
R&D
Requisition ID
3905190904