Role Summary
Provides specialist medical and scientific strategic and operational input into core medical affairs activities, including interactions with healthcare professionals and providers, generation of clinical and scientific data, medical education, and safety surveillance. Partners with marketing and commercial teams to inform brand strategies and support medical/marketing activities and market access. Drives asset strategy input and develops scientific communication platforms and integrated evidence plans to support launch readiness. Leads external stakeholder interactions and drives scientific communication initiatives across internal and external medical education, data, guidelines, and value proposition.
Responsibilities
- In collaboration with Global 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, area/affiliate medical teams, to provide strategic input into core asset strategy, and to drive medical activities.
- Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business 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.
- Reviews, assesses and reports applicable Adverse Events (AEβs) and Serious Adverse Events (SAEβs) if assigned to AbbVie conduct on clinical studies.
- Leads the development and execution of advisory boards, scientific and medical education programs. Provides scientific/medical education to all relevant internal stakeholders 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 Migraine and specific therapeutic area resource. Initiate research projects and drive them to completion, resulting in high quality publications.
- 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
- Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
- Typically, 15 yearsβ experience in the pharmaceutical industry or equivalent. Minimum of 10 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
- Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
- Expert knowledge in a relevant therapeutic specialty.
- Proven ability to run a clinical study or medical affairs cross-functional team independently.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess excellent oral and written English communication skills.
- People leadership experience preferred.