Medical Director, Specialty Pipeline, US Medical Affairs

Does a role as a medical affairs business leader involved in shaping the US launch excellence pathway for multiple specialty assets sound exciting to you? As Medical Director, Specialty Pipeline you will use your clinical and scientific training to define and drive the medical affairs business planning strategy for assets in various stages of development. You will be responsible for elevating the voice of US patients early and continuously in an asset's lifecycle and ensuring US Market needs/insights are considered and integrated into product development, evidence generation, and launch plans. All while partnering closely with commercial New Product Planning, Market Access, Global Medical Affairs, and R&D teams.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Support the Executive Director, US Medical Lead - Specialty Pipeline to develop deep understanding of the patient journey and US healthcare environment across diverse disease areas including hepatology, neurology, nephrology, and various areas within immunology and evolving, emerging areas of interest.

• Strategic partnership with the early Global Medical Leads and asset leads across functions (i.e. Market Access, New Product Planning, Evidence Generation) bringing disease area expertise & thinking and delivery of associated strategic deliverables. Partner with commercial and market access colleagues in review of market research materials.

• Be ambitious for patients by partnering with US RWE Evidence Generation teams to develop an early and deep understanding of medical unmet needs and innovative solutions to close identified gaps.

• Partner with Global Medical, Medical Communications & Scientific Training, and Medical Information, to ensure timely creation of medical materials that align with US medical strategy and business needs for both MSL and field payer teams.

• Lead strategic planning of medical tactics to support launch excellence; lead development of medical material and US scientific communication asset plans while adapting approach to align with asset archetype.

• Develop a deep understanding of the external environment and competitive knowledge/current trends for assigned assets and uses this knowledge to re-assess the target medicine profile throughout development.

• Represent GSK at external events, including medical conferences and advisory boards. Build and maintain relationships with key external stakeholders such as KOLs, medical societies, and patient advocacy groups.

• In partnership with the Executive Director, provides input into the design of clinical development plans, and integrated evidence planning; coordinates with relevant Global Medical colleagues, Medicine Development Leads (or their designee) and other technical experts, as required.

• Provide input into the selection of US investigators for clinical trials and investigator sponsored studies in alignment with the medical strategy. Collaborate with clinical operations to monitor and engage with key sites of interest.

• In collaboration with the field medical lead, where applicable, develops the early external engagement strategy and leads/contributes to appropriate US scientific engagement between GSK and external stakeholders/accounts in order to advance scientific and medical understanding including the appropriate development and use of our medicines, management of the disease, and patient care.

• Apply sound medical governance for all activities. Model the culture and create a delivery mindset of future ready innovation which supports faster, more agile yet specific solutions for HCPs and patients.

• Support the Executive Director, USMAL (US Medical Affairs Lead) or Medical Affairs TAH (Therapeutic Area Head), as needed.

• Must be US-based for consideration.

Why you?

Basic Qualifications:

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

• MD, PhD, PharmD or equivalent level of education.

• 5 + years Medical Affairs experience or a combination of medical affairs and clinical development industry experience.

• Experience leading strategic asset planning; developing and executing Medical Affairs strategies and plans.

• Experience designing educational content for medical science liaisons in the field.

• Experience leading and managing cross-functional work; experience working with the US market and knowledge of FDA requirements and compliance guidelines.

Preferred Qualifications:

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

• Experience in either neurology, hepatology, nephrology, immunologic diseases, or specialty medicine development.

• Understanding of US promotional codes/regulations, FDA regulatory submission process, and/or US labelling.

• Understanding of the drug development process through life cycle management including launch support.

• Demonstrated experience delivering business presentations to executive-level leadership.

• Ability to thrive is a dynamic work environment and to flex your skillset to adapt to asset archetype; ability to work effectively in a cross-functional team environment and manage a diverse group of responsibilities with good project management skills.

• Demonstrated ability to build strong internal and external networks.

• Ability to handle ambiguity and uncertainty, make appropriate prioritization decisions and drive projects to completion.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

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

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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