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Global Medical Affairs Lead, Early Vaccines

Employer
GSK
Location
Rockville, Maryland
Salary
Competitive
Closing date
Sep 23, 2022

View more

Discipline
Health Sciences, Medicine, Vaccine Research
Organization Type
Pharma
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Job Purpose

Provide global medical affairs leadership across a portfolio of pipeline assets in early stages of research and development (R&D) up to licensure, ensuring consolidated strategic medical input into R&D and commercialisation strategies. Drives the integration of insights from HCPs, patients, and the health care landscape into the asset(s) profile in alignment with the global medical accountabilities as per the GSK integrated asset operating model.

Collaborative working 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.

Key Responsibilities
  • Provides global medical affairs leadership for an assigned portfolio of assets in early development, which may include viral, bacterial, or targeted immunotherapies assets providing strategic medical insights into R&D and commercialization strategies.
  • Responsible for strategic alignment with clinical development, central and regional partner functions, to develop and optimize the evidence generation plans in support of the scientific value proposition of assigned assets and aligns resource needs.
  • In alignment with the Global Medical Portfolio Lead (GMPL) the GMAL will implement and lead the early GMAT and represent as appropriate the assigned assets at governance boards / meetings.
  • Lead the creation and execution of the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for assigned asset(s)/ indication(s).
  • Provides medical thought leadership and therapy area expertise to strategic portfolio discussions including anticipated changes in disease landscape, treatment paradigm and evolution of Policy/Payor scenarios in key LOCs to optimize data generation and life-cycle management plans globally.
  • 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. Provides scientific insights to validate asset and recommendation assumptions during the technical and commercial review process.
  • Drives 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.
    • Develop 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.
    • Oversees 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.
  • Provides direction, support and guidance to Senior medical manager and medical managers.


Required qualifications and previous experience:
  • Physician, PharmD or PhD.
  • Significant industry and/or clinical experience in the relevant field, acquired through global/regional/Local Medical Affairs
  • Knowledge and understanding of the development process from asset inception, early development, launch and lifecycle management. Robust understanding of GCP regulatory/ market access and reimbursement requirements.
  • Must be able to clearly demonstrate a thorough understanding of US healthcare environment including all external stakeholders.
  • Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience preferred.
  • Must demonstrate disease area expertise and appropriate medical and/or clinical experience.


Additional relevant job skills and abilities
  • Deep knowledge of healthcare environment.
  • Strong analytical skills to be able to assess and interpret scientific data and ability to input into the design and implementation of Phase 2 & 3b /4 studies.
  • Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
  • Demonstrated ability in engaging, building and sustaining a broad and strong external (expert) network.
  • Strong understanding and track record of adherence to the ethical, regulatory, compliance and legal framework which underpins all interactions with the external environment.
  • Experienced communicator on scientific/medical topics in fora of different audiences, including advisory boards, public panel discussion, interaction with policy makers. Ability to be a GSK spokesperson with media.
  • Proficient in managing multiple projects, budgets, and matrix interactions (internal / external consistent with each research project).
  • Proven ability to strategically prioritize, deliver on time while embracing cultural diversity in complex environments.
  • Track record of successful people management experience.


GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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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