Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities and market access. Drives MA input into and influences the development of asset strategy. Provides specialist medical insights, and executes on data generation, communication, and expert engagement activities as deliverables to relevant ASTs for both early and late stage development program including leading or contributing to: comprehensive gap assessment, development of Scientific Communication Platform, development of integrated evidence plans to support launch readiness. Drives scientific communication initiatives.

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.