Global Medical Affairs Lead, Belimumab
Site Name: UK - London - Brentford, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence Posted Date: Jun 7 2021 Purpose of the role: This role is the owner of the Belimumab Global Medical Strategy. Accountable for creating and developing the strategic direction, business / resource planning and team leadership on a global level. Creates an environment of strong team spirit, good communication and high motivation to enable inspired and effective team members to achieve the set goals. Advances reputation of GSK and the Immuno-Inflammation Medical Affairs organization with leading experts. The purpose of the role is to drive scientific leadership for Belimumab with the current Team of leaders, solid and compliant medical strategy and exemplary medical performance as part of the integrated brand ambition, delivers insight generation and gathering and builds plans for evidence needed (in partnership with MCL and R&D and other teams within GMA, VEO - Value Evidence & Outcomes). The GMAL Belimumab, is accountable for the integrated evidence strategy and plan that supports the lifecycle management of the asset and upcoming potential pipeline assets that can potentially fit, including launches and new indications. The GMAL Belimumab acts as the single voice of Medical Affairs into R&D and Commercial within the Lupus / Immuno-Inflammation Therapy Area. The GMAL Belimumab is accountable for defining the Medical strategic direction for the asset in strong partnership with MCL and MDL e.g. Lupus and new indications and contributing to the overall lifecycle management of GSK's portfolio. The successful candidate is core member of Respiratory, Immunology & Specialty, Classic & Established Products Leadership Team and MDT and MCT with the MCL for Belimumab. The GMAL Belimumab is accountable for designing Phase IIIb and IV evidence generation studies, including post-approval commitments. Works very close to the MDLs within the Lupus Space. Develops and delivers the Integrated Evidence Generation Plan (spanning late stage development and post launch market access support) and acts as the single voice of Medical Affairs into R&D and commercial for the medicine. The GMAL Belimumab is a member of both the Medicines Development Team in R&D and the Medicines Commercialisation Team which are instrumental in developing early assets and assessing business development opportunities. The GMAL role is a unique opportunity for an experienced, innovative and motivated Medical Affairs leader to provide strategic global medical affairs leadership for Belimumab. The opportunity and need for a strong medical affairs leader are great. This is another exciting and critical time as more Belimumab new potentially label expanding studies are completing requiring launch planning; the number of patients in the US is expanding, China has recently launched Belimumab, and many more forward moving events are occurring. The successful applicant will be accountable to continue to execute and develop the global Medical Affairs strategy for Belimumab; provide scientific and medical leadership in global cross functional teams, provide strategic and tactical guidance to LOC MA teams, as well as educate leading decision makers and healthcare professionals in the key LOCs as well as global ones. This GMAL Belimumab role will act as the single voice of Global Medical Affairs and have decision making accountabilities across a range of GMA responsibilities. The GMAL will be a member of both the Medicines Development Team in R&D and the Medicines Commercialisation Team as well as other cross functional groups. The Global Medical Affairs Leader is accountable for the global integrated evidence strategy, plan, and team. Working in close partnership with R&D, the GMAL will deliver, in collaboration with clinical, VEO, and other stakeholders the evidence needs for the asset. The GMAL will lead the global medical affairs team, a cross top-market medical affairs team, the global belimumab supported studies team, and the integrated evidence generation team. The role reports to VP Global Medical Affairs Primary & Specialty Care Therapy Area. Key responsibilities for Belimumab: Ensure global strategy is effectively communicated and executed at regional and country levels and that key LOC needs are appropriately accommodated in global deliverables and vice versa. Lead a team of global medical and scientific professionals within Belimumab to contribute to business planning, strategic partnering with MCLs, MDLs, to plan and deliver scientific engagement and medical performance for potential new assets. Drives the creation of the scientific narrative for the brand. Drive the scientific objectives and medical plan for the assets. Accountable with the team to work within GSK's compliance framework. Chairs all advisory boards with compliance, focus, dynamism, science and aiming towards outcomes and efficiency. Develops scientific strategic partnership with global guidelines bodies and interacts when needed with Global Regulatory agencies like FDA, EMA, JFDA, CFDA as well as relevant access bodies. Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy. Engages with high levels of proactivity towards scientific leadership with LOCs and Commercial Partners. Gathering medical insights from the key external stakeholders to inform and shape belimumab strategy. Working closely with the commercial leader and others to optimize plans in support of continued launch optimisation and life cycle strategy (integrated evidence plans) Core member of the medicines development team (MDT) Lead the Global Medical Affairs (GMA) team as well as develop the talent within the team Create & Lead the top market LOC Global Medical Affairs Team (GMAT) Lead the global Integrated Evidence Team (IET) & directly accountable for the global Integrated Evidence Plan (IEP). Accountable for execution of the medical plan for the asset throughout its lifecycle Accountable for Further Development and implementing scientific platform for the scientific communication strategy Leading the global scientific engagement strategy for the asset, including at scientific congresses, advisory boards or other company organised events where appropriate. External HCP and patient group engagement strategy, developing strong relationships with multiple external stakeholders. Chairman and leader of the belimumab global supported studies team, responsible for strategy and delivery Accountable for the compassionate use strategy Accountable for publication strategy and data dissemination plan Candidate Profile Medical Doctor, with demonstrated rheumatology/immunology expertise (either at clinical level or in pharma) - lupus specific experience preferred. Previous experience working with belimumab or other mABs, notably in major markets. Proven track record for high performance delivery in Medical Affairs Experience in the interaction and exchange of scientific information (in adherence with GSK scientific engagement principles) Strong communication & collaborative team working skills, as the role involves interface with a wide range of stakeholders internally and externally Experience engaging and delivering with global LOC perspective with a priority focus on top market LOC. Mixed experience of strategic and operational track record in Medical Affairs. Experience in execution at country and ‘above country' Medical Affairs Leadership roles. Successful track record in Global leadership Roles Experience in drug development (Research & Development) and understanding of GCP regulatory and market access reimbursement requirements. Excellent presentation, influencing and media skills for both internal and external audiences. Outstanding people management and development skills Ability to lead and contribute to a global cross-functional team of senior leaders If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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