SightGlass Vision: Global Head of Clinical, Medical & Professional Affairs

Job Description

Who We Are
SightGlass Vision, Inc., a joint venture company between CooperVision and EssilorLuxottica, is the inventor and manufacturer of novel spectacle lenses that have proven to strongly reduce the progression of myopia in children. With this game changing technology in hand, we are poised to improve the life of millions of children worldwide.

Why Work With Us
We are a small but growing enthusiastic team and as such we recognize each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We have a nimble start-up mentality and are backed by the world leaders in vision care products. We are friendly, inventive, and dedicated. Our lenses don’t just change vision, they change lives. Join a team that is passionate about improving children’s visual health and quality of life.

Job Summary
We are looking for an OD/Optometrist with extensive experience of leading clinical, medical and professional affairs functions within the ophthalmic medical device industry to become the face of SightGlass Vision as our Head of Clinical, Medical & Professional Affairs.

You will develop and lead all aspects of SGV’s Clinical Affairs Program Planning and execute both pre-market and post-market trials across multiple geographic regions. Creating and implementing clinical strategy for SightGlass Vision, you will oversee the scientific, statistical, regulatory and compliance requirements of clinical research.

With significant demonstrable experience of strategic communication, you will be an adept public speaker, confident in responding to questions from experts in the field and objection handling, and making data relevant for the customer. You will be an expert in professional education (product & generic) via training and presentations as well as developing content for key clinical conferences. You will continually build SightGlass’ reputation through widely networking in the Global Ophthalmic community with your passionate interest for myopia control technologies that will help our customers succeed in the battle against the epidemic of myopia we face.

Providing strategic and operational leadership to the global clinical and medical affairs teams, this role is critical in SightGlass Vision’s growth as your team will develop & approve promotional claims creation, KOL development & support, devising publication plans, creating clinical and scientific communications, organizing advisory boards, designing post-marketing clinical trials, investigator-initiated studies, and post-market surveillance.

With a focus on creating and driving a culture of continuous improvement within the organisation globally, the Head of Clinical, Medical & Professional Affairs will collaborate with leadership peers to establish initiatives to ensure a rounded overall approach to developing and growing the overall business.

Essential Functions & Accountabilities

1. Responsible for setting the overall strategy, execution and budget of the Global Clinical, Medical & Professional Affairs function, in addition to playing a key role in the planning and directing of activities for the total business as a member of the Senior Leadership Team.
2. Lead and develop innovative clinical and medical affairs strategies and tactics to build understanding and clinical credibility of Contrast Management as a fundamental tool in the treatment of myopia.
3. Lead the team to deliver clinical trial strategy, development and reporting.
4. Oversee clinical and medical affairs milestones and achievement to established milestones.
5. Develop technical marketing materials such as publications, reviews sales and marketing materials for clinical and technical issues.
6. Plan, execute and report on post-market surveillance activities and on post-market clinical follow-up studies.
7. Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
8. Establish and develop a scientific advisory board, leading interactions with academic thought leaders and clinical investigators.
9. As lead SGV representative externally within the community, represent the company to external audiences, including the investment, medical and regulatory communities.
10. Provide the clinical voice of SightGlass Vision, standing as the final arbiter of clinical expertise in dialogue with key external stakeholders, the SGV Board and Joint Venture Partners.
11. Drive companywide focus on clinical excellence and development of products, communication and safety with clinical data at its core.
12. Create and manage clinical aspects of regulatory strategies and interactions with Health Authorities.
13. Build effective and credible relationships with academic thought-leaders and investigators.
14. Prepare IRB submissions, maintain requirements and paperwork and file annual reports and develop regulatory clinical documents (i.e., PFG, Pl, PIB, etc).
15. In collaboration with the SVP RAQA, ensure product procedures and documentation meet regulatory standards and ensure compliance with regulatory requirements associated with conducting clinical studies.
16. Oversee medical safety including product attributes, complaint handling and AE handling in coordination with Regulatory and Quality functions.

SightGlass Vision’s management team is committed to the development 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

1. The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company’s clinical strategies and progress to a wide audience, including the CEO, the Board of Directors, Company employees, and the investor community.
2. Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company.
3. Must have outstanding executive presence and good commercial acumen with the ability to actively engage in management team strategic conversations.
4. Understanding of relevant FDA regulations and guidelines as well as those of the EU and other health authorities.
5. An understanding of the medical device industry.
6. Experience or knowledge of the prescription spectacle lens industry is a plus.
7. Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines, and post market surveillance requirements of EU MDR.
8. Must be science and data driven.
9. Demonstrate entrepreneurial spirit and ability to work in a start-up scenario.
10. Must have a results-oriented work ethic and a positive, can-do attitude.
11. Effective leadership, people management, communication skills and a team builder management style are essential; must be willing to be ‘hands on’.

Work Environment

1. Typical office environment or remote office.
2. Ability to be in the UK Head office 1 week per month preferred.
3. Willingness and ability to travel is essential, it is anticipated that this will be 30% of work time.
4. Due to the global scope of some projects involving several time zones, the ability to accommodate meetings outside of typical daily work hours from time to time is required.
5. This is a high growth, fast-paced, small organisation. The ability to be productive and successful in an intense work environment is critical.

Experience

1. Previous experience managing clinical and medical affairs functions.
2. 10 years’ experience in the ophthalmic and medical device industry.
3. Multiple years of management experience leading clinical/medical & professional affairs teams.
4. A proven success record in Class I and II clinical research studies and trial design as well as experience of FDA and marketing approval-directed filings (510k etc).

Education

1. Essential: OD or Optometrist and/or PhD in Optometry/vision science.

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