Global Medical Director - Nucala
- Research Triangle Park, NC
Site Name: USA - Pennsylvania - Philadelphia, USA - North Carolina - Research Triangle Park
Posted Date: May 14 2020
GSK has been at the forefront of respiratory science for more than 50 years - searching for new medicines and better ways to take them. We invest more in respiratory research than any other pharmaceutical organisation developing medicines that have transformed the treatment of asthma COPD and other respiratory diseases. Nucala is a medicine within the GSK respiratory portfolio that is at a critical stage to further consolidate within the SEA (Severe Eosinophilic Asthma) space, EGPA and potentially bringing 4 more indications to markets.
We have an exciting opportunity for a Global Medical Director to join the Nucala Team in the Respiratory Franchise. The Global Medical Director, Nucala is a pivotal role, enabling a talented physician/scientist with a track record of success to work with the VP of Biologics, Global Medical Affairs for Nucala and to contribute to global medical affairs evidence generation and launch optimization strategies across major markets.
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 VP, Respiratory Biologics
• Work closely with Global Medical Affairs team to optimise development plans.
• 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 Franchise/ R&D colleagues, including:
o Supporting the efficient working of the Integrated Evidence Team;
o Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need;
o Developing assigned Franchise study protocols.
• Drive excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
• Leads gathering medical insights from the Franchise 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, ensuring compliance with SE governance and documentation requirements.
• Inputs to the design and delivery of phase 3b/ 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, Zinc MAPs etc).
• 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 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.
• Works with GMAL in providing medical governance oversight for the asset, including the management of product-related issues/ crises.
• Medical Doctor
• Industry experience within respiratory / allergy medical affairs
• 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 understanding of 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 networks of external and internal experts
• Specialist qualification relevant to Respiratory / Allergy (preferred)
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