Director of Medical Affairs

The Director of Medical Affairs has global medical affairs responsibility to provide therapeutic and clinical expertise to support the development of ophthalmic medical devices, supporting systems. and also provide strong inputs on long term product opportunities and portfolio strategies.

The incumbent will work closely with the Regional Clinical Trial Management (CTM) teams to support evidence generation and dissemination activities that support product approvals, claims development, product adoption and life cycle management. In addition, close collaboration is required with the Research & Development (R&D) team during product development, and with marketing and commercial teams during product launches to provide training and education.

The Director of Medical Affairs will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions.

He/she is a member of the Data Safety Monitoring team to ensure adverse events from clinical research studies are reviewed and handled as appropriate.

Key duties and responsibilities:

• Contribute to the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator-initiated research
• Participate in Key Governance Forums, Cross Functional Leadership Teams, Portfolio Management Teams, Safety and Quality Review Boards, Complaint Investigation Teams
• Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care, uncover critical insights
• Provide support to Marketing, Communications, Legal, R&D, Quality Assurance (QA)/Risk Management/Product Safety and Commercial teams with medical and scientific insights to drive optimal business strategic direction and tactical business activities
• Collaborate with evidence generation colleagues from R&D and regional CTM teams to develop global strategies for evidence generation relating to new and existing products, regulatory approval/clearance, health technology assessment, customer access, and post-marketing support
• Provide scientific and medical expertise, medical oversight and approval for clinical trial concept, design, analysis, and report clinical research in assigned areas
• Provide medical oversight of materials to be used for study execution (investigator brochures, training materials, etc.)
• Provide medical inputs and expertise during the analysis of study results
• Partner with QA teams to support the following Post Market Surveillance (PMS) activities, but not limited to the evaluation of adverse events and complaints trend
• Provide expertise and advice on potential product involvement/impact; provide Health Hazard Assessment for field safety corrective actions
• Work with Regulatory Affairs (RA) and regional CTM partners to prepare reports on clinical investigations for submission to regulatory agencies and/or for publication, and to meet evidence requirements
• Provide medical insights/expertise for the risk assessment review of all products, including but not limited to risk-benefit analysis, medical inputs etc.
• Account for the medical content of internal product documentation and regulatory submissions of new products and renewals
• Approve Design History Files, Instruction for Use and Clinical Evaluation Plans / Reports (CEPs/CERs) as part of the creation of product-specific design dossiers/technical files as necessary
• Review and approve educational, promotional and reporting materials for use by internal partners
• Support in the address of any medical related requests/queries from Competent Authorities / Notified Bodies
• Strategize and prioritize publication proposals in collaboration with Clinical Documentation / Clinical Science
• Coordinate activities of external Regional Medical Monitors

Education

• At least 7 years relevant experience in post graduate medical education including: specialty residency, fellowship or subspecialty training
• A current license to practice is preferred and Board Certification or an equivalent is strongly preferred

Experience

• Minimum 5 years in clinical cataract surgery practice
• Dedicated research or other related advanced training or experience is preferred
• Significant experience with clinical research is a plus
• Previous industry experience leading Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business is a plus
• Experience in and understanding of product risk evaluation and mitigation preferred

Skills

• Strong leadership skills and able to demonstrate ability to build successful relationships with internal and external partners globally
• Strong communication and negotiation skills to successfully influence and implement policies with key customers and partners
• Membership and leadership roles in specialty Professional Societies is desirable
• Capable and has the expertise and success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas
• Demonstrated success in medical data generation, interpretation and publication highly preferred.

Travel requirements

• Up to 60%