Global Medical Affairs Lead (Director/Senior Director), Early Vaccines
Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville Posted Date: Mar 1 2021 The Global Medical Affairs Lead, Early Vaccines will be responsible for providing medical leadership and developing and implementing the global medical scientific strategic plan for assets in early development by integrating insights from HCPs, patients and the health care landscape into the asset profile in alignment with the global medical accountabilities as per the GSK integrated asset operating model. They will work collaboratively with diverse business partners across R&D, commercial, value evidence, and regional/priority Local Operating Companies (LOCs) medical teams will be critical to ensure optimal evidence generation strategies are in place for successful registration, access, and overall launch readiness for assigned asset in early pipeline. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Accountable for creation and execution of the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/ indication(s). Participate and shape the medical strategy as a member of the Early Development Team (EDT). Provide medical thought leadership and accountable for the medical affairs section of the integrated asset plan in alignment with the global medical accountabilities e.g. disease landscape, external engagement plans etc. Bring expertise to strategic discussions regarding the evidence requirements by leveraging an understanding of anticipated changes in disease landscape, treatment paradigm and evolution of Policy/Payor scenarios in key LOCs to optimise data generation and life-cycle management plans globally. Delivers the evidence needs for assigned assets in partnership with R&D: Drive the efficient working of the Integrated Evidence Team (IEP); ensuring insights from priority LOCs are integrated appropriately to inform the IEP. Inputs to the design and delivery of phase 2 trials, to generate data needed for signal generation, data gaps and Life-Cycle Management (LCM) plan. Provide scientific insights to validate asset and recommendation assumptions during the technical and commercial review process. Drives excellence in scientific engagement with key stakeholders (HCPs, Patients, Payers and Regulators) to gather medical insights and build a deep understanding of customer needs to inform and shape the asset's development programme. Drive delivery of designated above-country elements of the MAP ensuring compliance with GSK statutory governance and documentation requirements and provide the overall framework/guidance for evidence generation activities. Development of Areas of Interest (AOIs) to support a clear (Investigator Sponsored Study) ISS program. Reviews local GSK-sponsored and ISS proposals from Key LOCs to assess their scientific merit and strategic need, liaising with R&D technical experts. Oversee strategy for medical congresses and ensure scientific points are tied to TPP. Develops and reviews publications / abstracts/ posters related to the product, key competitors and relevant disease area(s) and accountable for the Data Dissemination Plan (DDP). Responsible for ensuring plans and activities are implemented in a manner that is compliant with Scientific Engagement principles, GSK's Code of Practice and GSK values. Providing medical governance oversight for the asset, including leading the management of product-related issues/ crises with potential impact on patient safety. Ensures that all communications (internal and external) are scientifically accurate, balanced, remain aligned with product strategy, and compliant to applicable laws and regulations. Effective management of medical budget (MAP and IEP) for assigned assets. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MD or PhD 10 plus years of industry and/or clinical experience in the relevant field, acquired through global or regional/Local Medical Affairs or non-Medical Affairs relevant functional areas: e.g. regulatory affairs, clinical, epidemiology, market access, discovery etc. Experience in vaccine or drug development across early development, launch and life cycle management & GCP regulatory/ market access & reimbursement requirements & promotional codes/regulations. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong analytical skills to be able to assess and interpret scientific data and ability to develop, design and implement Phase 2 & 3b /4 studies. Experience in infectious diseases or vaccines Experience and familiarity with US Healthcare Environment Demonstrated ability in engaging, building and sustaining a broad and strong external (expert) network. Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment. Experienced speaker on scientific/medical topics in fora of different audiences, including Advisory boards, public panel discussion. Proficient in managing multiple projects, budgets, and matrix interactions (internal / external consistent with each research project). Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK 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. 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