Clinical Project Lead, Publications, Surgical Franchise, Clinical R&D

Key Responsibilities:

• Provide clinical functional review and expertise on the assigned projects/tasks

• Review, critically analyze and present scientific data from clinical studies (internal and externally conducted). Designing and providing oversight of clinical research programs as assigned

• Building relationships with key opinion leaders and applies their input to enhance study design and protocols

• Ensures clinical research program design meets scientific objectives and is aligned with commercial needs

• May serves as the single point of contact in core teams in R&D, leads Clinical sub teams, and acts as the medical/scientific consultant to marketing or research project teams and government regulatory agencies

• Leads the planning, conduct, and reporting of clinical studies throughout the medical device development

• Oversees and resolves operational aspects of clinical trials (in collaboration with the Clinical Trial Team) in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.

• Will be responsible for post marketing studies, and training of customer facing medical affairs associates worldwide.

• Act as the primary point of contact for the Clinical evaluation team and provide support in Life Cycle Management/Postproduction risk review activities as assigned.

Key Requirements/Minimum Requirements

• Bachelor’s Degree or Equivalent years of directly related experience in clinical research in Ophthalmology/Optometry or Masters or PhD in Vision Science or related field.

• Experience in planning, conducting, and reporting of clinical trials in medical ophthalmic devices. Experience in working with notified bodies, conducting prior research with industry and/or developing novel clinical endpoints in vision science/physiological optics is a plus.

• The ability to fluently read, write, understand, and communicate in English

• 5 Years of Relevant Experience  or post-doctoral fellowship in the relevant area (i.e. vision science)

• Work hours: 40 hours

• Travel Requirements: 10% International

• Sponsorship available: No

• Relocation: No

Preferred Qualifications/skills Experience:

• Degree in Optometry/Ophthalmology/Vision Science

• Experience in writing clinical study protocols,

• Experience in planning, conducting, and reporting Clinical research in vision science.

• Experience in clinical trials regulations example, GCP, ISO standards.

• Experience in the field of intraocular lenses, vision science, physiological optics, binocular vision/accommodation is a plus

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