The US Medical Affairs Lead for Specialty New Medicines is focused on providing US medical leadership, input and support for emerging assets in development, ensuring US Market needs/insights are considered and integrated into product development, evidence generation, and launch plans. This role will also work with the US Specialty Therapeutic Head to ensure the US Medical team has the appropriate expertise and resources in place to support new medicines coming to market. They will partner closely with Commercial New Product teams, Global Medical Affairs, and R&D teams.

• Maintains understanding of US market dynamics and treatment landscape associated with priority pipeline assets in the Specialty Medicine Research units.
• Serves as the US representative on pipeline Global Medical Affairs teams and co-creates medicine strategy and plans; Represents US Medical Affairs interests across matrix teams to ensure medical plans represent the needs of the US business
• Gathers and communicates medical insights from internal and external stakeholders (Investigators/HCP's, Patients, Payors and Regulators) to shape product development decisions, Global Medical Affairs Plans, and integrated evidence strategy and plan.
• Develops the US strategy and operational plan for Specialty assets in the pipeline laying the initial foundation for future US Medical Affairs launches; Performs advanced scenario-planning and preliminary preparation for US launches
• Inputs into the design of Clinical Trials, development plans, and Integrated Evidence planning; coordinating with relevant Global Medical Team roles and R&D technical experts e.g. Global Value Evidence and Outcomes and Epidemiology as required.
• Understands and communicates clinical and market access data requirements for US market; shapes clinical and health outcomes evidence plans to support anticipated US Market needs
• Partners with Global Medical Affairs on Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements
• Leads US Medical/Clinical Operations partnership process, determining scope of US Medical Affairs support for ongoing US Clinical Trials.
• In partnership with US Medical Affairs Lead and US Head, ensures early input into priority US research site strategy (COEs, Cooperative groups, Research Networks); builds external relationships in partnership with Field Medical and collaborates with internal R&D stakeholders to foster internal relationships with external experts & leaders.
• Facilitates preparation for GSK Product Investment Board reviews and other governance meetings, ensuring compliance with timelines and required inputs
• Collaborates with the Group Head of the Field Medical Team and other relevant internal stakeholders on pipeline progress in order to inform field strategy and resourcing.
• Serves as Medical point for US input into Business Development and Acquisition opportunities
• In partnership with US Medical Communications and Scientific Training team, shapes, reviews, and approves Globally created Scientific Communication and Medical Information materials that will be used with US HCPs, ensuring alignment with US medical strategy and business needs
• Effectively manages transition of assets to Medical Matrix/Launch teams
• Accountable for budget management to plan

• Education: PharmD, PhD, nursing, allied health professional (eg, epidemiology) or other Advanced scientific degree.
• Experience: 5+ years of experience in Pharmaceutical Industry with Medical Affairs experience

• Medical Doctor- Board Certification (or equivalent credentials)
• Demonstrated success leading and managing cross-functional work
• Drug development (early through late stage) experience with knowledge of GCP regulatory/ market access and reimbursement requirements.
• US Medical Affairs and life cycle management preferred, including launch support requirements.
• Demonstrated ability to build strong internal and external networks.
• Significant diverse disease and therapeutic area knowledge.
• Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
• Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
• Demonstrated ability to build strong internal and external networks.
• Ability to effectively collaborate and influence in a highly matrixed environment.
• Adaptable to a dynamic environment and shifts in business priorities
• Strong business acumen including:
  • understanding of medicine development stages, clinical development, and lifecycle planning
  • market research
  • understanding of asset forecasting and resource planning
• Experience leading and coaching medical professionals
• Experience leading through change

Please visit to learn more about the comprehensive benefits program GSK offers US employees.

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