Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Director, Clinical Operations, to be located in Santa Ana, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
JJSV goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.
JJSV has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
The Director, Clinical Operations is responsible for developing, planning, and executing the strategic direction and leading the JJV – Surgical Vision 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 national and international 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. This person will work with Executive Management from multiple Strategic Partners and Service Providers to ensure that key performance indicators are met. Serve as a partner 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. Other responsibilities include:
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.
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.
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.
Provide insight, advice, and support to other groups in Clinical Affairs and R&D on study design and execution.
Perform other related duties as assigned by management.
Experience and Education Requirements:
Bachelor’s Degree in a Scientific discipline
Master’s or Ph.D. Degree in Scientific Discipline preferred.
7 or more years of industry experience in the 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 and Good Manufacturing Practices to medical device studies.
Strong working knowledge of statistical methods used in analyzing clinical hypotheses.
Demonstrated strong track record of leadership, collaboration and people development.
Defines and implements department or division strategies by serving as technical expert in GCP, GMP, and productivity processes (e.g., 6-sigma). Understands the interrelationship among functions and with other business areas.
Identifies and manages risks and business needs. Ensures the development and implementation of leading-edge systems and practices within Clinical Operations and across departments.
Develops departmental initiatives to maximize efficiency, optimize cost-effectiveness, and provide customer value.
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.
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.
Excellent project management and strong scientific and technical presentation skills.
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.
United States-California-Santa Ana-
Johnson & Johnson Surgical Vision, Inc (6234)