Global Medical /Scientific Affairs Director, Respiratory, Open to flexible working
GSK has been at the forefront of respiratory science for more than 40 years - searching for new medicines and better ways to take them. We have invested more in respiratory research than any other pharmaceutical organisation, developing medicines that have transformed the treatment of asthma and other respiratory diseases like COPD.
The COPD Ellipta portfolio, which is focussed on, Anoro and Trelegy, provides patients and GSK with a complete once daily portfolio to optimise patient care and enable delivery of the right medicine for the right patient. Evidence from the development programs including the IMPACT study have been instrumental to informing medical practice for how inhaled medicines for COPD should be positioned and are a key component to GSK's future success. Both medicines have been launched globally including Japan and China most recently and there is an extensive ongoing phase IV programme of studies to meet additional evidence needs, with an emphasis on real world data. This provides an exciting landscape with a diverse range of different evidence generation and medical affairs activities as part of a comprehensive and cohesive COPD portfolio level strategy
The Global Medical/ Scientific Director, COPD is a pivotal role within S&PC TA, enabling a talented physician or scientist with a track record of success to contribute to driving medical affairs strategy and execution globally.
Working closely with the VP/ Medical Affairs Lead COPD and GMAL Trelegy, you will support the consolidation of input from multiple internal and external stake-holders, develop the Integrated Evidence Strategy & Plan for their asset(s), together with responsibility for supporting the planning and execution of phase IV studies, including post-approval commitments.
Your role will be to:
- Contribute to the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/ indication(s) under the direction of the Medical Affairs Leader COPD (MAL COPD).
- Work closely with LOCs including Global Medical Affairs Team (GMAT), the Clinical Development Leader (CDL) and Medicine Development Leader (MDL) to optimise planning and execution,
- Lead/contribute to designated elements of the above-country Medical Affairs Plan e.g. Advisory Boards; Symposia.
- Partner with commercial colleagues to develop brand campaigns and support launches.
- Develop and approve promotional, non-promotional and training materials.
- Deliver the evidence needs of that asset in partnership with S&PC TA/ R&D colleagues, including:
- Supporting the efficient working of the Integrated Evidence Team;
- Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need;
- Developing assigned GMA study protocols.
- Drive excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
- Deputise for the MAL or GMAL as required.
- Supports the MAL/ GMAL in gathering medical insights from the TA LOCs and external stakeholders (HCP's, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan.
- Leads aspects of Advisory Board design and discussion, as requested by the MAL/ GMAL, ensuring compliance with SE governance and documentation requirements (SE Approval Templates; GLASSES etc).
- Inputs to the design and delivery of phase 4 studies, coordinating with relevant R&D technical experts e.g. Value Evidence & Outcomes and Epidemiology as required.
- Supports preparation of materials for the Portfolio Investment Board review/ Brand Planning processes.
- Develops and approves promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Content Lab etc).
- Contributes to Strategic Publications Plan (SPP), 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.
- Supports the MAL/ GMAL in communicating the clinical and market access data to the Franchise LOCs, ensuring a robust understanding of risk: benefit of our medicines.
- Enhances local tactical plans and shares best practices to support Launch Excellence.
- Supports the MAL/ GMAL in providing medical governance oversight for the asset, including the management of product-related issues/ crises.
- Medical degree, Pharm D, or PhD
- 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 in the respiratory therapeutic area
- 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 networks of external and internal experts
- Specialist qualification relevant to Respiratory
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