- 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%).
- 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%).
- Responsible for managing Clinical Supplies Unit (20%)
- 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%).
- Provide insight, advice, and support to other groups in Clinical Affairs and R&D on study design and execution (10%).
- Perform other related duties as assigned by management (5%).
Director of Clinical Operations - Irvine, United States - Johnson & Johnson
Description
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.
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.
Visit us at Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.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 R&D, 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.
Customer Focus - Develops departmental initiatives to maximize efficiency, optimize cost-effectiveness, and provide customer value.
Interdependent Partnering - Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership on major initiatives that have high impact for the business. Key member of leadership team. Applies influence across departments and the business.
Organizational & People Development - Accountable for assessing talent, capabilities, gaps, and plans to close gaps and ensuring organizational depth to meet present and future business needs, looking across J&J companies.
Serves as a change agent for global effectiveness.Adheres to environmental policy, procedures, and supports department environmental objectives. Engages in Credo-based decision-making
Builds cross-functional and cross-departmental support for innovative solutions and
mentors/facilitates successful team behavior. Partners with Clinical Scientists to ensure that project deliverables are met.
Oversees multiple clinical studies across a product platform and directs/mentors other study managers in study execution within that product platform.
Manages relationships externally with Strategic Partners, including study investigators,hospitals/surgery centers, universities, research institutions, and CROs.
Adheres to environmental policy, procedures, and supports department environmental objectives.
Essential Functions/Responsibilities: