MD or PhD/Pharm D
Must possess an active medical license and be board eligible or board certified or equivalent
Pharmaceutical industry and medical affairs experience.
Must be able to clearly demonstrate a thorough understanding of the US healthcare environment including all external stakeholders.
Must demonstrate disease area expertise and appropriate medical and/or clinical experience.
Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience preferred.
• Leads/contributes to defined US medical affairs work for a medicine(s) and supporting global franchise, clinical development, US medical matrix team(s) and US medical commercial strategy team(s).
• Contributes to the development and execution of the US Medical Affairs Plan (UMAP) and the medical sections for the strategic launch plan for one or more medicines.
• Integrates US environment needs and medical voice of customer (patients, providers, payers) into medical affairs strategy.
• Deeply understands, interprets and applies the external environment and competitive knowledge in all medical plans and is able to define the medical story for the patient.
• Ensures the US environment needs for medical and health outcomes evidence generation are represented and incorporated into the global medical work.
• Recommends scientifically appropriate measures within health outcomes research over the lifecycle of the medicine(s) to meet US reimbursement needs.
• Leads/contributes to the design and delivery of Phase IIIB/IV studies (US Pharma funded) in collaboration with global franchises, acts as medical monitor where appropriate and manages US funded investigator sponsored studies as appropriate.
• Leads/contributes to appropriate US scientific engagement between GSK and external communities in order to advance scientific and medical understanding including the appropriate development and use of our medicines, the management of disease, and patient care.
• Ensures US external experts are appropriately engaged over the life cycle of the medicine in close collaboration with field medical.
• Partners with all stakeholders to ensure delivery of all assigned medical activities to support life cycle management, ensuring integrity of scientific content.
• Applies sound medical governance for all activities and is accountable for medical governance sign off.
• Works closely with safety, regulatory, and manufacturing to ensure best benefit-risk assessment and ability to quickly integrate relevant changes.
• Serves as US medical affairs point for all safety issues.
• Accountable for maintaining deep product and disease area expertise and maintaining a deep understanding of patient and physician interactions and clinical decision making and impact. May include accountability of other medical staff for execution of work and people development for one or more medicine(s).
• Leads/contributes to copy approval process.
• Supports the USMAL or Medical Affairs TAH as needed.
• For vaccines sponsored studies, serves as Local Medical Lead (LML) and provides local (US/Canadian specific) support to the study design; provides medical/scientific leadership to the local study conduct team and manages all local medical activities required before study start, during the study and after study completion and analysis; provides input on local risk management activities and medical oversight on study quality.
You may apply for this position online by selecting the Apply now button.
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