Medical Director, Hepatology

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 Scientific Director, Specialty Pipeline you will use your clinical and scientific training to define and drive the medical affairs business planning strategy for assets at various stages of development. You will be responsible for elevating the voice of US patients throughout asset lifecycle and ensuring US Market needs/insights are considered and integrated into medicine profiles and evidence generation plans. You will partner closely with commercial early asset leads, 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;

• Supports the US Medical Affairs Lead to develop deep understanding of the patient journey and US healthcare environment across diverse disease areas including hepatology, infectious disease and neurology.

• Strategically partner with the GMALs, MDLs or their designee(s) bringing disease area expertise & thinking.

• Be ambitious for patients by partnering with data analytics to develop an early and deep understanding of medical unmet needs and innovative solutions to close identified gaps.

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

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

• 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.

• Responsible for connecting across pipeline TA teams and the wider enterprise to ensure best practice sharing and evolution of the role of the pipeline team.

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

• In partnership with the US Medical Affairs Lead, provides US input into medical profiles, development plans, and integrated evidence planning; coordinates with relevant Global Medical colleagues and R&D (Research & Development) technical experts, e.g., Global Value Evidence and Outcomes and Epidemiology, as required.

• Provide input into the selection of US investigators for clinical trials and investigator sponsored studies in alignment with the medical strategy.

• Partner with commercial and market access colleagues in review and approval of market research materials.

• In collaboration with the field medical lead 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.

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

Why you?

Basic Qualifications:

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

• MD, PhD, PharmD. 

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

• Previous experience with promotional content review and approval.

• US Launch experience.

Preferred Qualifications:

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

• Experience in either infectious disease, hepatology, or specialty medicine development.

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

• Pref: Strong business acumen with demonstrated success leading and managing cross-functional work.

• Pref: Ability to thrive is a dynamic work environment and to flex your skillset to adapt to asset archetype.

• Pref: Demonstrated ability to build strong internal and external networks.

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Why GSK?

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

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