Scientific Director/Senior Medical Director, Medical Affairs - Eye Care

Role Summary

Provides specialist medical and scientific strategic and operational input into core medical affairs activities, including health-care professional interactions, generation of clinical and scientific data, educational initiatives, and patient safety activities. Works closely with commercial teams to provide strategic medical input into core brand strategies and to support medical affairs, marketing activities and market access. Drives asset strategy, develops scientific communications, and leads or contributes to data generation and expert engagement across early and late stage development programs.

Responsibilities

• In collaboration with Medical teams, Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications/projects. Works closely with Brand Teams and relevant cross-functional medical teams, to provide strategic input into core asset strategy, and to drive medical activities.
• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy. Develops innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally.
• Provides scientific and technical support for assigned assets; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Asset, Development and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy.
• Provides scientific and technical input to inform the development of the Asset Target Product Profiles (TPP). Provides input in design and execution of Phase II-III trial programs including target population and endpoint selection aligned with TPP. Works cross functionally to lead the development of the asset Phase 3b/4 strategy.
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
• Provides scientific/medical education to investigators, clinical monitors, and project team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
• Lead functional and cross functional teams responsible for discrete projects within the specific therapeutic area (data analysis, expert engagement, individual publications, study collaborations).
• Represents Medical Affairs in due diligence activities for the acquisition of assets aligned with the Disease Area Strategy.
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

Qualifications

• Scientific Director: Advanced Degree in sciences (PhD, PharmD, OD). Eye care experience preferred.
• Scientific Director: 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
• Scientific Director: Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
• Scientific Director: Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred.
• Scientific Director: Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Scientific Director: Ability to run a clinical study independently with little supervision.
• Senior Medical Director: Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred. Eye care experience preferred.
• Senior Medical Director: Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred.
• Senior Medical Director: Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Senior Medical Director: Ability to run a clinical study independently with little supervision.
• Senior Medical Director: Ability to interact externally and internally to support global business strategy.
• Senior Medical Director: Must possess excellent oral and written English communication skills.