US Medical Affairs Lead, Meningococcal Vaccines
Posted Date: Jan 23 2023
US Medical Affairs Lead, Meningococcal 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 meningococcal vaccines portfolio. This role will report to the VP and TA Head, US Vaccines 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 GSK’s US Meningococcal Vaccines portfolio 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.
- Leads defined US medical affairs work for meningococcal vaccines and supporting global franchise, clinical development, US medical matrix team(s) and US commercial strategy team(s).
- Contributes to the development and execution of the US Medical Affairs Plan (UMAP) and the medical sections for the strategic launch plan for the Pentavalent MenABCWY vaccine
- 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 vaccines 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 medicines, the management of disease, and patient care.
- Ensures US external experts are appropriately engaged over the life cycle of the medicine 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. May include accountability of other medical staff for execution of work and people development for one or more medicine(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 and scientific directors supporting the portfolio
We are looking for professionals with these skills to achieve our goals
- Medical Doctor, PharmD, PhD in life sciences. Specialization in vaccinology, immunology, infectious diseases, microbiology, virology, life sciences, public health, paediatrics or health economic policy are preferred.
- At least 5 years industry and/or clinical experience in the relevant field, acquired through Medical Affairs or non-Medical Affairs relevant functional areas: e.g. regulatory affairs, clinical development, public health, epidemiology, market access, discovery etc.
- Experience working effectively in large enterprise matrix teams.
- Project management, and leadership/management experience. Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
- Must be able to clearly demonstrate a thorough understanding of US healthcare environment including all external stakeholders.
- Must be able to demonstrate understanding of medical affairs accountabilities for setting strategic direction, evidence generation, external engagement, and internal advice; direct experience preferred.
- Must 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
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 impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using the science of the immune system, human genetics and advanced technologies to get ahead of infectious diseases, HIV, cancer and other immune-mediated and respiratory diseases. We do all this with a commitment to operate responsibly for all our stakeholders by prioritising Innovation, Performance and Trust.
Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and medicines, including innovative new products, will reach more people who need them than ever before.
We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That’s why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.
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.
Find out more:
Annual Report 2021
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 impact the health of 2.5 billion people around the world in the next 10 years.
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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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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