The Director of Medical Affairs provides leadership and management within the Surgical Business of medical and scientific support for approved products.
You will assist in the development of phase IV and Investigator Initiated Studies, peer to peer education of doctors, scientific publication and investigation of safety issues and business development. Act as the thought partner to marketing and R & D on designing Clinical Development Programs, labeling, and communications all within compliance parameters.
Takes an active role in managing Phase IV clinical programs supporting both products in development as well as marketed product globally.
Provide near and long term strategic direction of the scientific platform and play a major role in developing the research agenda for the surgical Business Unit.
Develop and maintain relationships externally with advisory boards, professional associations, professional meetings and conferences, etc. to achieve business unit objectives.
Ability to lead direct reports and oversee large scale projects. Individuals in this position collaborate with internal stakeholders, external customers and key thought leaders to develop phase IIb/IV research initiatives, and create clinical education and support programs.
Maintains a high degree of market place knowledge, medical trends and works closely with the sales and marketing group to provide clinical input for marketing initiatives, sales materials, education and training. Industry specific knowledge of medical, legal regulations, procedures, and practices that impact the business.
The successful individual must possess a strong ability to interpret and communicate clinical studies. The ability to recommend, present and defend appropriate product claims, scientific opinions and interpretations for products in prelaunch, launch and post launch phases.
Oversees the development and distribution of scientific and medical information to effectively provide accurate, quality, and up to date information to internal and external customers while meeting appropriate legal and regulatory requirements.
Must have the ability to forge strong external relationships with KOLs, PBMs and the FDA.
This individual will act as a liaison between the company and clinical investigators. Develops credible relationships with opinion leaders, medical directors, and key regulatory officials.
Build functional excellence by attracting and retaining top quality talent, maintaining strong external relationships, and maintaining strong internal lines to ensure appropriate flow of medical information.
Provides editorial content and comments for phase IV clinical study reports & manuscripts. Manages Phase IV clinical programs.
Position requires 30 – 40% domestic travel and 20% foreign.
We are seeking a candidate with the following qualifications:
7 – 10 years in ophthalmic industry, Medical Device Industry. Demonstrated experience with several products, led through clinical development, regulatory approval, and launch. MD/OD/PHD with Surgical or ophthalmic experience.