Global Medical Affairs Lead, Liver Disease
Site Name: USA - Pennsylvania - Upper Providence, UK - London - Brentford Posted Date: Nov 8 2021 Purpose of the role: GSK has an investigational medicine in development at GSK for the treatment of cholestatic pruritus (itch) in patients with primary biliary cholangitis (PBC). A well-executed medical affairs strategy will be critical in achieving meaningful insight gathering, appropriate clinical investigation and focused scientific communication/medical education. The GMAL role is a unique opportunity for an experienced, innovative and motivated Medical Affairs leader to provide strategic leadership for the asset. This is a critical time as the global team pursues phase 3 clinical trials and engages with colleagues and healthcare practitioners in key markets to develop a shared understanding of the assets potential role in evolving treatment pathways in preparation for a global launch. The successful applicant will report to the Global Medical Lead Early Assets & Hepatology within Global Specialty Medical Affairs. You will develop and execute the Medical Affairs strategy for the asset and provide scientific and medical information to leading decision makers and healthcare professionals in key countries. Working in close partnership with R&D, you will identify the evidence and education needs for the asset and develop and deliver the Integrated Evidence Plan (spanning late stage development and post launch market access support). You will be accountable for Medical Affairs launch excellence and Phase 4 evidence generation studies, including post-approval commitments and health outcomes studies. As leader of the Global Medical Affairs Team you will also be a key member of the Medicine Development Team in R&D and the Medicine Commercialisation Team. Key accountabilities: Gathering medical insights from the key external stakeholders to inform and shape asset Medical strategy; identifying gaps and opportunities based on emerging data, competitor activity and understanding of diverse healthcare systems Working closely with the Medicines Development Lead, Medicines Commercialisation Lead and others to plan a reimbursable file, and optimise launch and life cycle strategy, including key input to and, once a launch commitment is secured, leadership of the Integrated Evidence Team With colleagues from key market GSK Local Operating Companies, leading co-creation, refinement and execution of the asset's Medical Affairs strategy throughout its lifecycle Maintaining and implementing a scientific communications framework and formulating the scientific communication strategy, including oversight of training materials for in-country Medical Affairs staff, delivery of a digital communications plan and responsiveness to key performance indicators. Leading the global scientific engagement strategy for the asset, including at scientific congresses, advisory boards or other events where appropriate. Developing strong relationships and effective interactions with multiple external stakeholders, including external experts, patient groups, governments, payers, learned societies, consortia and guideline developers. Contributing expertise in scientific issues related to clinical development, study design, data interpretation and study conclusions Deploying strong analytical thinking to quickly assess large amounts of information and distill into key messages and actions. Providing opinion based on deep knowledge of disease and emerging external environment, with clear focus on patients and unmet medical need Delivering phase 3b/4 studies, including post-approval commitments, if applicable. Taking accountability for the asset's medical governance and for certification of materials and activities to ensure they are compliant with GSK Code of Practice, standard operating procedures, and with external industry standards including the ABPI Code of Practice. Collaborating with the Medical Project Manager Hepatology, Specialty Medical Operations Lead and partners in Finance and Procurement to manage resources, vendors and budgets and deliver project-critical achievements on time. Candidate Profile Medical Doctor, Pharmacist or PhD, demonstrating hepatology or other relevant specialty expertise (either at clinical level or in pharma). Previous experience working in PBC or cholestatic disease, globally or in major markets. Evidence of alignment to GSK Values (Transparency, Respect, Integrity and Patient Focus) and working to GSK Expectations (Courage, Accountability, Teamwork and Development) Proven track record for high performance delivery in Medical Affairs or R&D at GSK or other companies. Ability to manage ambiguity, evaluate benefit and risk and take appropriate accountability for decision making Experience in the effective exchange of scientific information, maintenance of high professional standards and adherence to internal and external codes of practice Skilled at simultaneous consideration of scientific data and practical healthcare delivery from diverse health systems to optimise medical implementation of innovation. Strong listening, communication & collaborative team working skills, as the role involves interface with a wide range of stakeholders internally and externally Preferred Candidate Profile Hepatologist If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. 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