Medical/ Scientific Director - Trelegy and Anoro Global Medical Team
Contract until December 2022
Brentford / Remote
Up to £1420 per day via umbrella
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 Global Medical Affairs Leader (GMAL).
* Work closely with the Clinical Development Leader (CDL) and Medicine Development Leader (MDL) 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 TA/ 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 TA 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 GMAL as required.
Key responsibilities:
* Supports the GMAL in gathering medical insights from the GMAT 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 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, Content Lab 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.
* Supports the GMAL in communicating the clinical and market access data to the GMAT 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 GMAL in providing medical governance oversight for the asset, including the management of product-related issues/ crises.
Qualifications
* Medical degree, PharmD, PhD or equivalent
* 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.
* ABPI signatory (preferred).
* 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 (preferred).
