Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Director of Operations, Preclinical Research, Medical Device to be located in Raynham, MA, Somerville, NJ, Cincinnati, OH, Warsaw, IN, or West Chester, PA.
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.
The Director of Operations in the Preclinical Center of Excellence (COE) will lead the operations of the COE’s vivarium, which support the execution of preclinical studies development required to competitively position MD products for regulatory approval and clinical acceptance. This individual will work closely with preclinical franchise leadership to understand project requirements and timelines across all franchises to efficiently manage resources for preclinical study execution within the vivarium. The Director of Operations will be responsible for managing the quality system and leading external vendor management for the COE. The individual will lead for the COE and work closely with COE leaders to track goals and objectives. The Director of Operations will serve as a member of the Preclinical COE leadership team in developing an industry leading preclinical organization focused on innovation and patient safety.
The Director of Operations, Preclinical Research, Medical Device will:
• Develop and implement in source/out source strategy to drive preclinical study execution excellence and ensure timely delivery of project milestones within budget across MD.
• Develop and implement resource management strategy to efficiently manage vivarium staff and utilization to deliver value to MD.
• Ensure excellence in execution of internal preclinical animal studies to deliver on NPD goals across MD. Effectively address any barriers which may arise that will delay studies.
• Provide leadership and direction to prioritize vivarium and study related-staff to align with business objectives.
• Partner with COE leadership in franchises to develop accurate resource allocations and budgets for preclinical evidence strategies.
• Manage and prioritize vivarium budget to meet key business objectives.
• Oversee the development and implement procedures to provide animal care and welfare that meets or exceeds AALAC and USDA requirements.
• Direct the management of attending veterinarians and external contractors including animal care technicians and surgical support staff to deliver world class animal care.
• Oversee the management of the COE quality system including the implementation and oversight of procedures and processes. Responsible for lab audits and CAPAs.
• Partner with Preclinical franchise leaders to identify and prioritize critical equipment and model capabilities needed in COE labs.
• Develop and implement vendor management strategy to assess, monitor and track performance/quality of external vendors used in the execution of animal studies. Ensure vendors are audited and compliant to company standards for GLP study activities and animal welfare.
• Develop and implement project tracking tools for the COE to manage preclinical project deliverables, resource constraints and track performance of the COE to its goals and objectives
• Talent Development: Develop and strengthen the preclinical operations and project management talent pipeline. Qualifications
• A minimum of a Bachelor's degree in biosciences or related field is required
• A minimum of 10 years of experience in preclinical/clinical operational leadership role in a pharmaceutical, medical device, or contract lab setting (or related industry) is required
• A minimum of 10 years leading, managing and developing staff at multiple levels is required
• A minimum of 8 years of project management experience and experience managing complex operational activities is required
• Proven track record of developing and implementing procedures to optimize workflow and resource utilization is preferred
• Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the transformation of a function is required
• Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required
• Experience with leading multiple projects, managing priorities, and resource management is required
• Knowledge of animal welfare and care regulations is preferred
• Knowledge of project risk management is preferred
• Familiarity with Medical Device Product Development is preferred
• This position will be located in Cincinnati, OH and will require up to 20% domestic and international travelPrimary Location
United States-Ohio-CincinnatiOther Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Massachusetts-Raynham, North America-United States-Indiana-Warsaw, North America-United States-New Jersey-SomervilleOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Trial AdministrationRequisition ID