Director Clinical Research & Clinical Operations

Company: The Cooper Companies
Location: Pleasanton
Posted on: May 3, 2021

Job Description:

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

Job Summary:

Directs and oversees clinical research staff in the strategic planning, execution, and management of clinical trials for short, medium, and long-term research and product development projects in the ophthalmic/medical device industry.

Directs and oversees Clinical Operation Team to execute operational activities for international clinical investigations during product research and development for contact lens, myopia control and lens care products. Uses expert level knowledge of clinical trial design, contact lens technology and ocular physiology to guide product development teams through insightful clinical evaluation. Fosters and develops external clinical partnerships to expand clinical research capability and capacity.

Essential Functions & Accountabilities:

• Directs a staff of employees to execute the planning, coordination, execution, and analysis of research & development clinical trials.
• Directs and oversees the day-to-day operations of the Clinical Operations Team including essential clinical documentation and management of device availability and accountability for internal and external clinical studies.
• Oversees development, implementation and maintenance of appropriate standard operating procedures, standard work, and policies to ensure compliance of regulations, guidelines, and standards for clinical studies.
• Determines and manages clinical trial costs, budgets, and forecasts.
• Oversees and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports as well as publications based on the clinical studies/research.
• Uses expert level knowledge of clinical trial design, statistical analysis, contact lens technology and ocular physiology to guide product development teams through integration of all aspects of the research and development process including lens design, clinical performance, lens metrology and manufacturing processes.
• Establishes partnerships and agreements with external clinical research organizations, universities, and individuals to expand the clinical research capabilities and expertise available to accomplish research and development objectives.
• Provide leadership skills to promote the growth and career development of Clinical Research staff members.
• Publishes or presents in scientific forums when appropriate.
• Travel up to 5% as required for site qualifications and scientific conferences.

CooperVision's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Qualifications

Knowledge, Skills and Abilities:

• Expert level knowledge of contact lens or medical device clinical evaluation techniques, contact lens clinical performance, clinical trial design, and protocol development.
• Exceptional analytical and problem-solving ability, creative and inventive skills, good communication skills required to interface with cross-functional groups, clinical sites, regulatory bodies, outside consultants and marketing. Excellent organizational and coordination skills are essential.
• Proven track record in establishing and conducting programs of clinical research that have contributed to progressing the understanding of the interaction between and a device and the ocular environment.
• Acknowledged opinion leader in a clinical discipline demonstrated by publication track record in peer reviewed journals and/or extensive authorship of industrial research reports.
• Proven project management skills and/or program management experience with strong leadership skill.
• People management, staff development and leadership skills are essential.
• In-depth understanding of Good Clinical Practice and US/EU/Canadian medical device regulations and related standards and guidelines
• Develops close working relationships and communications with projects teams and cross-functional personnel.
• Proficient with technology and systems necessary to manage and present data. Intermediate skill in the use of Excel, Word and PowerPoint; advanced preferred.

Work Environment:

• Normal office environment. Occasional work in clinical setting.

Experience:

• Minimum 15 years of experience in the ophthalmic medical device industry or academia especially in clinical research, product development, and data analysis.

Education:

• Optometric degree and a master's degree or PhD in the clinical sciences required; a candidate with a MD/ with an MS/PhD may be considered with strong product development experience in the ocular field (anterior segment of the eye) and an exceptional track record.

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Keywords: The Cooper Companies, Pleasanton , Director Clinical Research & Clinical Operations, Other , Pleasanton, California