Assoc. Director, Preclinical Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Multi-Family Pre-Clinical Development – Medtech

Job Category:

People Leader

All Job Posting Locations:

Cincinnati, Ohio, United States of America

Job Description:

We are searching for the best talent for an Associate Director, Preclinical Operations to be located in Cincinnati, OH.

Purpose: The Associate Director, Preclinical Operations will serve as a leader of operations, which supports the execution of preclinical studies required to competitively position Johnson & Johnson MedTech products for regulatory approval and clinical adoption.  The position works closely with the preclinical department leaders to understand project requirements and timelines, and to efficiently acquire and manage resources for preclinical study execution within the department. The Director of Preclinical Operations is also responsible for managing a team that will drive quality and continuous improvement metrics, as well as leading external vendor management for the Preclinical Research department.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Quality System Management
  • Responsible for the development of Quality Metrics to drive quality improvement initiatives.
  • Establish, track, and maintain a risk assessment process for phase audits
  • Oversee the management of the Preclinical Research Archiving
• Training Management
  • Directs staff in the development of Preclinical Training curriculum
  • Develops Project Planning templates and training for all staff
• Directs staff in the development and implementing Document Control management
• Resourcing Management
  • Directs process improvements – develop/implement continuous improvements to processes.
  • Responsible for the optimization of resourcing model(s) for scenario building to drive resource optimization and efficiency.
  • Ensure Development and implementation of end to end project/program plans and timelines. 
• Oversee the Management of vendors (e.g., CROs), their audit schedules, and approval of new vendors.
• Partner with preclinical leaders to identify and prioritize critical equipment for acquisition, and new model capabilities required to support the business testing needs.
• Develop and implement tools for the preclinical department to manage/track preclinical study deliverables, identify resource constraints and evaluate performance towards G&Os.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring that subordinates follow all company guidelines related to health, safety and environmental practices, and that all resources needed are available and in good condition.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Education and Required Experience:

• Masters in Business Administration Degree, with specialization in Operations required
• 7+ years experience managing Operations in an industry setting required
• Experience in the Medical Device industry or medical field preferred
• Demonstrated knowledge of Preclinical practices, and procedures
• Advanced knowledge of 21 CFR part 58 and part 820 and their application
• Experience in managing complex projects driving continuous improvement
• Ability to communicate effectively to both subordinates and leadership
• Experience in managing full time and contracted staff
• Demonstrated experience in GDP requirements for medical devices
• Demonstrated experience in GLP study execution for regulatory submission
• In depth understanding of GLP Test Article Management
• In depth understanding of GLP Archive Management
• Demonstrated experience in Quality System Management
• Demonstrated experience in Pr