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Global Medical Affairs Lead, Early Assets (1)

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Closing date
Aug 12, 2021

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Discipline
Health Sciences, Medicine
Organization Type
All Industry, Pharma
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jul 26 2021 Purpose of the role: We are building a new team in GSK, with a mission to bring critical Medical Affairs input to our assets in the early Specialty and Primary Care pipeline. This team will support programs from the Candidate Selection milestone through to Commit to Phase 2 or the appointment of an asset-specific Global Medical Affairs Lead. It will align with the Early Development Leaders (EDL) group in Research and with the Portfolio and Pipeline Strategy Group (PPSG) in Commercial, with which it will also support the medical evaluation of Business Development opportunities for the GSK pipeline. Providing targeted, focused support to a diverse portfolio of innovative assets will require novel and agile ways of working, connections to country-level Medical Affairs and external expert input, and an ability to combine scientific understanding with a practical grasp of patient unmet need, physician perspectives, treatment landscape and payer priorities. A successful team will support rapid progression of assets to the Commit to Phase 2 decision gate with indication sequencing, population segmentation and evidence generation plans informed by appropriately prioritised Medical Affairs insights. The eGMAL role is a unique opportunity for an experienced, innovative and motivated Medical Affairs leader to provide strategic leadership for the early portfolio. This is a critical role expected to enable better informed decision making for portfolio progression, earlier incorporation of prioritised medical insights into evidence planning, differentiation and launch readiness, and more rapid progress through early and late clinical development. The successful applicants will report to the Global Medical Lead Early Assets within Global Specialty and Primary Care Medical Affairs. You will develop and execute the Early Medical Affairs strategy for around 5 assets, driven by a focus on Who is the patient? To this end you will engage external experts, patient representatives and GSK Local Operating Company Medical Affairs teams to collect and prioritise insights that will inform populations, end points and development plans. Working in close partnership with R&D and PPSG, you will identify the evidence and education priorities for each asset and deliver the stage-appropriate chapters of the Integrated Asset Plan. You will also support the evaluation of Business Development opportunities as required, identifying medically relevant populations, end points and risks to support prompt decision making and efficient portfolio growth and progression. Key accountabilities for eGMAL: Providing global medical affairs leadership for an assigned portfolio of assets in early development, providing strategic medical insights into R&D and commercialization strategies: profiling patient pathways; mapping the treatment landscape and how it may evolve in the lifecycle of the asset; identifying gaps and opportunities based on emerging data, competitor activity and understanding of diverse healthcare systems Responsibility for strategic alignment with clinical development and central and regional partner functions, to develop and optimize the medicine profile and evidence generation plans in support of the scientific value proposition of assigned assets and aligns resource needs Leadership of the global scientific engagement strategy for the asset, including at scientific congresses, advisory boards or other events where appropriate. 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 portfolio's development programme. Providing Medical input to the review of Business Development opportunities Providing scientific insights to validate asset and recommendation assumptions during the technical and commercial review process. 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 distil into key messages and actions. Providing opinion based on broad knowledge and close study of disease and emerging external environment, with clear focus on patients and unmet medical need Taking accountability for the asset's medical governance and for approval 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 Early Assets, S&PC Medical Operations Lead and partners in Finance and Procurement to manage resources, vendors and budgets and deliver project-critical achievements on time, and to ensure smooth transition to an asset-specific GMAL when appointed. Candidate Profile Medical Doctor with specialisation or extensive industry expertise in one or more portfolio areas of focus (immune and inflammatory diseases, infections, neuroscience, cardiovascular, dermatology, respiratory, gastrointestinal) Examples of curiosity and agility; able to pivot to new areas of focus, assimilate information rapidly and identify critical questions that will drive decision-making and planning Evidence of alignment to GSK Values (Transparency, Respect, Integrity and Patient Focus) and working to GSK Expectations (Courage, Accountability, Teamwork and Development) as a leader Proven track record for high performance delivery in Medical Affairs or Clinical Development at GSK or other companies. Robust understanding of The breadth and complexity of clinical medical practice, including its variation in key markets A Medical Affairs approach to understanding and strategizing a disease area through critical insights into the needs, behaviours and priorities of patients, practitioners and healthcare systems The epidemiological and molecular correlates of disease which inform segmentation of patient populations and medically meaningful decision-making end points in clinical pharmacology Ability to manage ambiguity, evaluate benefit and risk and take appropriate accountability for decision making Ability to prioritise work and focus on critical deliverables 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 needs from diverse health systems to optimise medical implementation of innovation. Strong listening, communication & collaborative team working and leadership skills, as the role involves interface with a wide range of stakeholders internally and externally 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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