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K-779 Director Of Clinical Operations
hace 3 meses
Johnson Johnson Vision Care, Inc., a member of Johnson Johnson's Family of Companies, is recruiting for a Director, Clinical Operations located in Jacksonville, FL or Irvine, CA.At Johnson Johnson Vision, we have a bold ambition to change the trajectory of eye health.
That's why, through our operating companies, we've developed solutions for every stage of life—to help people see better, connect better, and live better.
We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond.
We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere.Position Summary:The Director, Clinical Operations is responsible for developing, planning, and executing the strategic direction and leading the JJV –Clinical Operations organization globally.
He/she has responsibility for the execution of all clinical studies worldwide and must ensure compliant, timely, and high-quality clinical studies globally in support of new product development, claims, in-market products, and business continuity projects.
Responsibilities include directing senior Clinical Operations individuals in executing US and OUS clinical investigations.This individual also has full responsibility for in-sourced, out-sourced, and off-shore resources responsible for executing all elements of clinical trials in a compliant and efficient manner.
He/she works with Executive Management from multiple Strategic Partners and Service Providers to ensure that key performance indicators are met.He/she also partners with leaders in multiple departments including RD, Clinical Sciences, Medical Affairs, Regulatory Affairs, and Global Strategic Marketing in support of the execution of clinical research strategies.
Masters Complexity - Defines and implements department or division strategies by serving as technical expert in GCP, GMP, and productivity processes.
Understands the interrelationship among functions and with other business areas.
Innovation – Identifies and manages risks and business needs.
Ensures the development and implementation of leading-edge systems and practices within Clinical Operations and across departments.Essential Functions/Responsibilities:1.
Lead, develop, and drive strategy for the Global Clinical Operations organization and its role within JJV.
Ensure execution of high-quality, timely, and compliant clinical studies to support new product development and in-market products (25%).2.
Direct Clinical Operations Managers and others as they execute clinical investigations for Global Platform teams.
Responsible for obtaining and optimizing use of resources to ensure project success, ensuring that all procedures comply with relevant regulations, guidance, directives, and standards (20%).3.
Responsible for managing Clinical Supplies Unit (20%).4.
Develop and drive key Strategic Partner relationships to ensure study execution is done in compliance with GCP, in an efficient and effective manner, within timelines, and on budget (20%).5.
Provide insight, advice, and support to other groups in Clinical Affairs and RD on study design and execution (10%).6.
Perform other related duties as assigned by management (5%).Qualifications:Required:· A minimum of a Bachelor's Degree in a Scientific Discipline· A minimum of 8-10 years' work experience in Clinical Operations in medical device or pharmaceutical industry· Strong organizational, communication, and interpersonal skills with ability to work effectively from both a functional and enterprise-wide perspective· Ability to negotiate effectively and to influence upper management and strategic partners to ensure that business goals are met· Excellent understanding of the concept and application of Good Clinical Practices in the pharmaceutical or medical device industries· Strong knowledge of quality systems and regulations· A minimum of 5 years of experience in people management· Excellent project management and strong scientific and technical presentation skillsPreferred:· Master's or Ph.D.
Degree in Scientific Discipline· A minimum of 5 years' experience as a clinical operations manager.· Broad understanding of medical devices/instrumentation used in optometry/ophthalmology.· Broad based technical knowledge and skills in diverse areas of business (e.g., Operations, QA, laboratory, regulatory, project management, etc.
).At Johnson Johnson, we're on a mission to change the trajectory of health for humanity.
That starts by creating the world's healthiest workforce.
Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
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.
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