Global Medical Affairs Leader - Oncology Early Strategy & Innovation, Open to flexible working
GSK is a science-led global healthcare company with a special purpose: To help people do more, feel better, and live longer. Our goal is to be one of the world’s most innovative, best performing, and most trusted healthcare companies. We have three global businesses that research, develop, and manufacture innovative pharmaceutical medicines, vaccines, and consumer healthcare products.
GSK’s Research & Development Pipeline in Oncology:
GSK Oncology is committed to the discovery and development of new and potentially life-changing therapies for patients with cancer. Our vision is for people with cancer to not only to live, but to live well, because we are delivering innovative and transformational medicines.
Working independently, the Oncology Early Strategy and Innovation Global Medical Affairs Leader (GMAL) is capable of fully leading the Medical Affairs strategic planning process and its implementation. The GMAL is accountable for ensuring optimal registration, access, and overall launch readiness for assigned compounds from the early oncology pipeline. The GMAL is responsible for shaping the oncology portfolio and communicating its strategy internally and externally.
This may include the following activities:
- Ensure the development and execution of strategies that drive clinical differentiation and insure successful fit to clinic for early pipeline compounds.
- Leverage an understanding of anticipated changes in Policy/Payor/Clinic models in US, and EU, Japan, Asia and LatAm, to guide development strategies. Plays an integral role in building/ optimising the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/ indication(s).
- Works closely with the Physician Project Leader and Early/Medicine Development Leader to optimise development plans and life-cycle management, and data generation.
- Drives delivery of designated above-country elements of the MAP e.g. Advisory Boards; Symposia.
- Partners with commercial colleagues to optimise development strategies in the Franchise Local Operating Companies (LOCs).
- Drives the development and approval of scientific, trial-supporting and training materials.
- Delivers the evidence needs for assigned assets in partnership with R&D:
- Drives the efficient working of the Integrated Evidence Team; ensuring insights from Franchise LOCs are integrated appropriately to inform the IEP.
- Development of Areas of Interest (AOIs) to support a clear (Investigator Sponsored Study) ISS program.
- Reviews local GSK-sponsored and ISS proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D technical experts.
- Accountable for the development of assigned Franchise study protocols.
- Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
- Deputizes regularly for the HIMS as required.
- Gathers medical insights from Franchise Local Operating Companies (LOCs) and external stakeholders (HCP’s, Patients, Payors, Regulators) to shape integrated evidence strategy and plan.
- Leads Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements (Approval Templates; GLASSES etc).
- High level of responsibility for successful delivery of critical projects and processes in the Franchise.
- Responsible for building and driving the global Medical Affairs strategy and inputs to IEP for assigned assets.
- Building credibility through the richness of his/her content expertise.
- Successful delivery of Medical Affairs plans in accordance with GSK and statutory requirements.
- Driving excellence in external engagement - building credibility with strong external network.
- Ensures appropriate medical governance including the management of product-related issues with potential impact on patient safety.
- Development of an GMA LCM plan for Life-Cycle Management (LCM) assigned compounds.
- Inputs to the design and delivery of phase 2 trials, to generate data needed for signal generation, data gaps and LCM, coordinating with relevant R&D technical experts e.g. Global Health Organization and Epidemiology as required.
- Oversee compound strategy for medical congresses and ensure scientific points are tied to TPP.
- Develops and reviews publications / abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DPP) is maintained in Datavision.
- Providing medical governance oversight for the asset, including leading the management of product-related issues/ crises with potential impact on patient safety.
- support the HIMS in effective management of medical budget (MAP and IEP) for assigned assets.
We are looking for professionals with these required skills to achieve our goals:
- Medical Doctor, PharmD or PhD level education
- Significant experience within within oncology medical affairs
- Drug development experience with knowledge of GCP regulatory/ market access and reimbursement requirements.
- Experience developing, designing and implementing Phase 2 & 3b /4 studies.
- Significant experience in Medical Affairs and life cycle management, including launch support requirements
- Understanding of promotional codes/regulations and review/approval processes.
- Experienced in working effectively in a complex matrix environment.
- Strong project leadership
If you have the following characteristics, it would be a plus:
- Oncologist or Hematologist
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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, colour, 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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