- GlaxoSmithKline PLC
- $152,300.00 -152,300.00/year*
112 Nyetimber Pkwy
Are you interested in a highly visible medical affairs role that allows you to design training and program content that educates and shapes awareness of our medicines? If so, this Medical Affairs Director role could be an ideal opportunity to explore.
Working independently, the Early Strategy and Innovation Scientific Director (ESID) is capable of fully leading designated aspects of the Medical Affairs strategic planning process and its implementation on behalf of the Global Medical Affairs Leader. The scope of the role therefore mirrors the full scope of the Global Medical Affairs, Head of Early Innovation & Medical Strategy (HIMS) role. The ESID is accountable for insuring optimal registration, access, and overall launch readiness for assigned compounds from the early oncology pipeline
In this role you will be 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. 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. 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. 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.
Key responsibilities: Develop and leverage strong cross-functional collaborations with Global Marketing, Global Development (EDTs and MDTs), Business analytics/market research, Global Scientific Communications, Medical Affairs teams in 8 key Local Operating Companies (LOCs), Global Value and Access, Regulatory, and Legal. Gathers medical insights from the Franchise LOCs and external stakeholders (HCP s, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan. Leads Advisory Board design and discussion, as delegated by the GMAL, ensuring compliance with SE governance and documentation requirements (Approval Templates; GLASSES etc). 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. Facilitates preparation for the aPIB review/ Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across Franchises/ Franchise LOCs. Plays an integral role in the development and approval of Scientific Communication materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc). Oversee compound strategy for medical congresses and ensure scientific points are tied to TPP for all congresses 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. Communicating effectively the clinical and market access data for their asset to the Franchise LOCs; ensures a robust understanding of risk: benefit. Develop and maintain expert council(s) to insure utilization of external inputs to strategy development Providing medical governance oversight for the asset, including leading the management of product-related issues/ crises with potential impact on patient safety. Will support the HIMS in effective management of the medical budget (MAP and IEP) for assigned assets.
Additional Responsibilities: High level of responsibility for the successful delivery of critical projects and processes in the Franchise. Responsible for building and driving the global Medical Affairs strategy and IEP for assigned assets. Building credibility through the richness of his/her content expertise. Responsible for the successful delivery of Medical Affairs plans in accordance with GSK and statutory requirements. Responsible for driving excellence in external engagement - building credibility with, and insights through, a strong external network. Ensures appropriate medical governance including the management of product-related issues with potential impact on patient safety. Develop and execute strategies and tactics to optimize medical activities and insure clinical differentiation and successful fit to clinic at time of commercial launch, for assigned compounds. Integrate an understanding of the evolving role of immune oncology, molecular genetics and personalized medicine to inform and develop new models supporting differentiation. Update management on the progress of projects and findings that could impact strategy. Leverage his/her understanding of molecular pathways and their relevance in specific disease areas and an in-depth knowledge/awareness of competitive activity and market dynamics of the hematology/oncology marketplace. Maintain a strong external focus and engage medical experts. Integrate anticipated changes in Policy/Payer/Clinic models, to inform Medicine Profile development, and optimal labeling.
We are looking for professionals with these required skills to achieve our goals: BS degree plus 10 years of industry and/or clinical experience in the oncology therapeutic area. Significant disease and therapeutic area knowledge. Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements. Ability to develop, design and implement Phase 3b /4 studies. Significant experience in Medical Affairs and life cycle management preferred, including launch support requirements. Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes. Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment. Demonstrated ability to build strong internal and external networks. Prior above country experience advantageous.
If you have the following characteristics, it would be a plus: Doctorate level (PharmD, PhD, etc.) plus 7 years of industry and/or clinical experience in the oncology therapeutic area. Strong organizational, planning, and business acumen skills Ability to prioritize business needs and flexibility to address them when business appropriate
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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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