Working independently, the Medical/Scientific Director is capable of fully leading designated aspects of the Medical Affairs strategic planning process and its implementation on behalf of the Global Medical Affairs Leader (GMAL) and in collaboration with her/his peers and other functions in the medical affairs team. The scope of the role therefore mirrors parts of the scope of the GMAL role, to whom she/he is accountable. This may include the following activities:
• Plays an integral role in building/optimising the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/indication(s).
• Drives delivery of designated above-country elements of the MAP, e.g. Advisory Boards, Symposia, Educational Events.
• Partners with commercial colleagues to optimise brand strategy, campaigns and launches in the Franchise Local Operating Companies (LOCs).
• Leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).
• Drives the development and/or approval of promotional, educational, training and other materials and responses.
• Drives the congress planning and coordination from a brand perspective, including pre- and post-congress deliverables
• Drives the scientific training coordination and execution from a brand perspective, including material development and/or approval
• Delivers the evidence needs for that asset on behalf of the GMAL in partnership with R&D:
o Drives the efficient working of the Integrated Evidence Team; ensuring insights from Franchise LOCs are integrated appropriately to inform the IEP.
o Reviews local GSK-sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D experts.
o Accountable for the development of assigned Franchise study protocols.
• Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
• Deputizes regularly for the GMAL as required.
• Gathers medical insights from the Franchise Local Operating Companies (LOCs) and external stakeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and global medical affairs plans and strategy.
• Leads medical lead research activities including Expanded Access Programs
• Leads Advisory Board design and discussion ensuring compliance with SE governance and documentation requirements
• Leads Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements
• Inputs to the design and delivery of phase IIIb/IV studies and EAPs, including post-approval commitments, coordinating with relevant R&D technical experts e.g. Global Health Organization and Epidemiology.
• Responsible for the review of local GSK-sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D, safety, biostats, and other experts.
• Facilitates preparation for the aPIB review / Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across Franchises/Franchise LOCs.
• Medical Doctor-Board Certification (or equivalent credentials) or extensive clinical and industry experience Oncology, PhD or PharmD
• Industry and/or clinical experience in the oncology therapeutic area
• Significant disease and therapeutic area knowledge.
• Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements.
• Significant experience in Global Medical Affairs and life cycle management, including launch support requirements.
• Robust understanding of promotional codes/regulations; previous involvement in review and approval processes.
• Ability to work across time zones and to travel
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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