Job Description - Director, Research Programs (RD0139)
Company: CTI Education Group
Posted on: April 8, 2021
Job Description - Director, Research Programs (RD0139) Job
Description Director, Research Programs - RD0139 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
- 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
- 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
- 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
- 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
- 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
- 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
- In-depth understanding of Good Clinical Practice and
US/EU/Canadian medical device regulations and related standards and
- 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.
- Normal office environment. Occasional work in clinical setting.
- 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. Affirmative Action/Equal Opportunity Employer.
Keywords: CTI Education Group, Coeur d'Alene , Job Description - Director, Research Programs (RD0139), Executive , Victor, Idaho
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