Senior Global Medical Affairs Lead, Early Vaccines

The Senior Global Medical Affairs Lead, Early Vaccines. will provide global medical affairs leadership across a portfolio of pipeline assets in early development ensuring consolidated, strategic medical input into R&D and commercialization strategies. Drives the integration of 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.

Key Responsibilities

• Key Responsibilities
  
• Provides global medical affairs leadership for an assigned portfolio of assets in early development, providing strategic medical insights into R&D and commercialization strategies.
• Responsible for strategic alignment with clinical development and 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.
• Accountable for GMATs and representation of assigned assets at governance boards
• Accountable for 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 optimise 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 SMM and MM

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Physician Degree
• 10 plus years of industry OR clinical experience with global/regional/Local Medical Affairs or relevant non-Medical Affairs functional areas: e.g. regulatory affairs, clinical, epidemiology, market access, discovery etc.
• Experience in the development process from asset inception, early development, launch and lifecycle management.
• Experience in GCP regulatory/ market access and reimbursement requirements.
• Experience with US healthcare environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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.
• Deep knowledge of US 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.

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, governance and control, managing ambiguity and paradox.
• Managing individual performance.
• Creating a performance culture and driving results, prioritisation, execution, delivering performance.
• Setting strategic direction and leading on-going organisational transformation.
• Building a resilient organisation.
• Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
• Managing P&L and capital allocation.
  
  

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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