US Medical Affairs Head, Disease Portfolio

About the Role

The US Medical Affairs (USMA) Head, Disease Portfolio will drive senior scientific leadership with strong and compliant medical strategy and exemplary medical performance as part of an integrated brand ambition. Deliver insight generation and builds plans for evidence needed in partnership with Medical Commercialization, Market Access, and Value Evidence & Outcomes – US and Globally.

The Head, Disease Portfolio is accountable for the USMA strategic plans that support multiple in-line and pre-launch assets in a portfolio of disease areas, including new indications. The Head, Disease Portfolio partners closely with Global Respiratory Medical Affairs VPs/Heads of the Solid Tumor and Hematology Disease areas, Global R&D Respiratory area leads, Regulatory area leads, and US VP & Head, Marketing.

The Head, Disease Portfolio is a core member of USMA TA Leadership team, US BU Leadership Team and Commercialization Strategy teams, and Global Medical Affairs strategic boards. The Head, Disease Portfolio is also accountable for ensuring evidence generation (Phase IIIb, IV, VEO) and publications plans meet US needs and address unmet patient needs.

This role reports to the VP & Therapeutic Area Head, US Medical Affairs

Key Responsibilities

• Lead a team of US medical affairs senior directors with responsibilities for for multiple assets in-line and launch readiness disease areas (12-24 months pre-authorization).
• Ensure novel and aligned medical objectives are thoughtfully incorporated into Global Respiratory Medical Affairs plans and US Integrated Brand Strategy to address unmet patient/provider needs and support strategic imperatives at the enterprise level.
• Create strong collaborative partnerships internally with key stakeholders: Global VP/Heads Medical Affairs, VP US Marketing, Global R&D Clnical Development area leads to foster strong communication, understanding, and advocacy for the US and Medical Matrix Teams for in-line and pre-launch assets and disease areas.
• Accountable for building strong priority external relationships and scientific engagement with key external experts, academic accounts, societies, patient advocacy groups in respective disease areas in support of USMA Portfolio-Level strategic engagement goals.
• Provide leadership for regulatory agency support as needed with FDA, label reviews, safety discussions, etc.
• Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy.
• Share medical insights and advocate with cross-functional partners to shift strategy and plans (US, Commercial, Global, Clinical Development, Regulatory) as needed and act based on informed US feedback from external stakeholders, including changes to protocol design, publication planning, evidence generation, integrated strategic plans, etc.
• Accountable for review of US VEO plans for in-line and pre-approval (12-24 months) in partnership with US VEO business partner and input into novel evidence generation to meet US needs.
• Help define strategic areas of interest and provide leadership to ensure US Investigator Sponsored Studies are moving through internal strategic and process pathways. Advise on development of US collaborative trials.
• Establishes exemplary collaboration with VP, US Marketing to ensure strategic alignment with Internal Brand Commercialization Teams within US Business Unit.
• Provide medical leadership and decision making for Promotional Review Committee escalations.
• Provide US medical input and expertise into potential BD&L activities related to respective disease areas.
• Responsible for leading and developing teams and people including recruitment and talent reviews.
• Accountable for financial planning and operational budget goals for in-line asset plans.

Why You?

Minimum Requirements

• Advanced Scientific Degree: MD, PharmD, PhD, or allied health professional with advanced scientific degree.
• 8 Years of Medical Affairs Experience
• Must have experience in US Medical Affairs

Preferred Requirements

• Clinical and industry expert in the specified therapeutic area
• Demonstrated success in inspiring/leading/managing teams and cross-functional work
• Drug development (early through late stage) experience with knowledge of GCP regulatory/ market access and reimbursement requirements.
• US Medical Affairs and life cycle management preferred, including launch support requirements.
• Demonstrated ability to build strong internal and external networks with superior external stakeholder management skills across clinical, scientific, population health, policy, and regulatory
• Significant disease and therapeutic area knowledge.
• Robust understanding of US promotional codes/ regulations; previous involvement in review and approval processes
• Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
• Excellent presentation and media skills for both internal and external audiences

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 positively impact the health of 2.5 billion people by the end of 2030.

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.

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