Early Medical Lead, Specialty Medicine

Job Purpose

The EML role provides medical leadership to support the progression of assets (Medicines or vaccines) to the Commit to Phase 2 decision gate, or beyond, with indication sequencing, population segmentation and evidence generation plans informed by appropriately prioritised Medical Affairs insights.

This is a unique opportunity for an experienced, innovative and motivated Medical Affairs leader to provide strategic medical leadership for the portfolio of assets. 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 role will develop and execute the Medical Affairs strategy for the portfolio of assets as well as partnering on the Integrated Evidence Plan

Work alongside R&D partners including Early Development Leaders (EDL), Medicines Development Leaders (MDLs), and others, according to stage, to identify the evidence and education needs for the asset to develop and deliver the Integrated Evidence Plan. Work in partnership and with the Portfolio and Pipeline Strategy Group (PPSG) in Commercial, and/or Medicines Commercialisation lead (MCL) as appropriate, with which it will also provide medical evaluation of Business Development opportunities for the GSK pipeline.

As assets progress through the pipeline, you will be accountable for preparing Medical Affairs launch excellence and Phase 4 Evidence Generation studies including post-approval commitments and health outcomes studies.

As a leader in the Global Specialty Care Early assets Medical Affairs Team, you will also be a key member of the cross-functional team relevant to the asset stage (for example, the Medicines Development Team in R&D and the Medicines Commercialisation Team)

Key Responsibilities

* To bring critical Medical Affairs leadership to our assets in the early Specialty Care pipeline supporting programs from the Candidate Selection milestone through to Commit to Phase 2 or the appointment of an asset-specific Global Medical Strategy Lead

* Working closely with the Medicines Development Lead, Medicines Commercialisation Lead, (or EDL and PPSG director as appropriate) 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

* Provide targeted, focused medical leadership to a potentially diverse portfolio of innovative assets focused within aligned disease areas: provide 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; lead on strategies to shape the future practice of medicine within specified and related disease areas

• 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 strategic input opinion based on broad knowledge and close study of disease and emerging external environment, with clear focus on patients and unmet medical need. Engage and collaborate with external experts to identify key medical unmet needs, physician perspectives, treatment landscape and payer priorities.
• Connect closely with LOC Medical Affairs, ensuring key market insights are captured and reflected in strategies in a timely way and are used to validate asset and recommendation assumptions during the technical and commercial review process.

* Ensure 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 communication 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 where required, including but not limited to: determining clinical value through working with external expert partners; input into determining the patient population and ensuring the lead indication fits the unmet need; determining readiness of the clinical environments for the innovation and what work (incl. EG) must be carried out to shape the practice of medicine; consider the overall IEP and ensure wider understanding of the total "cost" of an asset acquisition is considered.

* 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 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.

* Matrix leadership across multiple teams. Play a key role in delivering on team objectives on medicine development teams.

Qualifications / Experience

Basic Experience

* Medical Degree, PharmD or PhD in clinical / scientific discipline

* Therapy Area experience/expertise in specialty medicine across respiratory, immunology or infectious diseases

* In country experience as a Therapy Area Medical Lead

* Experience directing the strategy of an asset at a global level

* Experience working in clinical development

* Expertise in launching an asset at local and global level

* Asset lifecycle management expertise at local and global level

* Expertise in Data Generation in terms of asset development

* Experience of omnichannel strategies

Preferred Experience

* Robust understanding of

1. The breadth and complexity of clinical medical practice, including its variation in key markets.

2. 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.

3. The epidemiological and molecular correlates of disease which inform segmentation of patient populations and medically meaningful decision-making end points in clinical pharmacology.

An appointable candidate demonstrates at least two of the above, plus the agility to develop in the third.

* Experience in the effective exchange of scientific information, maintenance of high professional standards and adherence to internal and external codes of practice

* Evidence of alignment to GSK Values

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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