US Medical Affairs Lead, Herpes Zoster, Vaccines

As US Medical Affairs Lead, you will play a key strategic role in the development and execution of the US medical affairs strategy and support continued growth of GSK's shingles vaccine. This role will report to the VP and TA Head, US Vaccines Medical and Clinical and this person will be a member of the US Vaccines Medical Affairs Leadership Team. The role will provide you the opportunity to lead key activities to progress your medical affairs career including:

• Providing medical leadership and developing and implementing the US medical scientific strategic plan for Shingles by integrating insights from HCPs, patients, and the healthcare landscape into the asset profile in alignment with the US medical accountabilities as per the GSK integrated asset operating model.
• Collaborative working with internal and external diverse business partners across R&D, global medical affairs, commercial, value evidence, and public policy teams to ensure optimal evidence generation strategies are in place for successful registration, equitable access, and overall launch readiness for GSK's adult vaccine portfolio.
• Integrate US environment and medical voice of customer (patients, providers, payers) into medical affairs strategy.
• Provide leadership and best practice to broader medical affairs group through active involvement in the Vaccine medical affairs leadership team.

Key responsibilities:

• Leads defined US medical affairs work for Shingles and supporting global franchise, clinical development, US medical matrix team(s) and US medical commercial strategy team(s).
• Leads the development and execution of the US Medical Affairs Plan (UMAP).
• Integrates US environment and medical voice of customer (patients, providers, payers) into medical affairs strategy.
• Deeply understands, interprets and applies the external environment and competitive knowledge in all medical plans and is able to define the medical story for the patient.
• Ensures US needs for medical and health outcomes evidence generation are represented and incorporated into the global medical work.
• Recommends scientifically appropriate measures within health outcomes research over the lifecycle of the vaccine(s) to meet US reimbursement needs.
• Leads the design and delivery of Phase IIIB/IV studies (US Pharma funded) in collaboration with global franchises, acts as medical monitor where appropriate and manages US funded investigator sponsored studies as appropriate.
• Leads appropriate US scientific engagement between GSK and external communities in order to advance scientific and medical understanding including the appropriate development and use of our vaccines, the management of disease, and patient care.
• Ensures US external experts are appropriately engaged over the life cycle of the vaccine in close collaboration with field medical.
• Partners with all stakeholders to ensure delivery of all assigned medical activities to support life cycle management, ensuring integrity of scientific content.
• Applies sound medical governance for all activities and is accountable for medical governance sign off.
• Works closely with safety, regulatory, and manufacturing to ensure best benefit-risk assessment and ability to quickly integrate relevant changes.
• Serves as US medical affairs point for all safety issues.
• Accountable for maintaining deep product and disease area expertise and maintaining a deep understanding of patient and physician interactions and clinical decision making and impact. Includes accountability of other medical staff for execution of work and people development for one or more vaccine(s).
• Leads/contributes to copy approval process.
• For vaccines sponsored studies, serves as Local Medical Lead (LML) and provides local (US/Canadian specific) support to the study design; provides medical/scientific leadership to the local study conduct team and manages all local medical activities required before study start, during the study and after study completion and analysis; provides input on local risk management activities and medical oversight on study quality.
• Manages a team of medical directors supporting medical activities

Why you?

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

Basic Qualifications:

• Medical Doctor, PharmD or PhD in life sciences.
• Specialization in vaccinology, immunology, infectious diseases, microbiology, virology, life sciences, public health or paediatrics.
• At least 5 years industry experience in medical affairs within the US market.
• Experience of launching vaccines
• Experience of Vaccines lifecycle management
• Experience working effectively in large enterprise matrix teams.
• Demonstrate understanding of medical affairs accountabilities for setting strategic direction, evidence generation, external engagement, and internal advice.
• Demonstrate a thorough understanding of US healthcare environment including all external stakeholders.
• Project management, and leadership/management experience.
• Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.

Preferred Qualifications:

• Experience of another area in industry such as commercial, clinical development, regulatory affairs or market access.
• Demonstrate disease area expertise and appropriate medical and/or clinical experience.
• Strong analytical skills to be able to assess and interpret scientific data.
• Drug development experience across early development, launch and life cycle management with robust knowledge of GCP regulatory/ market access and reimbursement requirements and a good understanding of promotional codes/regulations.
• Demonstrated ability in engaging, building, and sustaining a broad and strong external expert network.
• Excellent written and verbal communication, including presentation skills.
• Experienced speaker on scientific/medical topics in front of different audiences, including advisory boards, public panel discussion.
• Willingness to travel - up to 20% working time

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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