Medical Advisor

Medical/ Scientific Director – Trelegy and Anoro Global Medical Team

Contract until December 2022

Brentford / Remote

Up to £1420 per day via umbrella

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 invest 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 Ellipta portfolio 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 for patients with Asthma and COPD. Evidence from the various development programs including the CAPTAIN and IMPACT studies have been instrumental to informing medical practice for how inhaled medicines for Asthma and COPD should be positioned and are a key component to GSK’s future success. Both Anoro and Trelegy have been launched globally for COPD and in US, Japan and other markets for Asthma. There is an extensive ongoing phase IV programme of studies focussed on Real World Evidence to address additional evidence gaps. This provides an exciting landscape with a diverse range of different evidence generation and medical affairs activities as part of a comprehensive and cohesive portfolio level strategy for Asthma and COPD

The Global Medical Director, Trelegy and Anoro is a pivotal role within the General Medicines TA, enabling a talented physician or scientist with a track record of success to contribute to global drug development and launch optimization.

Working closely with the VP/ Medical Affairs Lead and Global Medical Affairs Leader Trelegy, you will support the consolidation of input from multiple internal and external stake-holders, develop the Integrated Evidence Strategy & Plan (spanning late stage development and post launch market access support) for their asset(s), together with responsibility for supporting the planning and execution of all GSK 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 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).

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