Medical Director
- Brentford, England (GBR)
- £130 - £145 Per Hour
- 6 Months
- Start date: ASAP
- Ref: GSK0JP00076186
- Regulatory Affairs
- drug development
- governance
- business process design
- pharmaceutical
- gcp
- abpi
- launch support
Medical Director
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.
The COPD Ellipta portfolio of Relvar/ Breo, Anoro and Incruse, together with Trelegy, which has recently been launched in major markets, 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. 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. This includes landmark studies like IMPACT which will shape medical practice now and in the future.
We have an exciting opportunity for a Medical Director to join the COPD Team in the Respiratory Franchise. The Global Medical Director, COPD is a pivotal role, enabling a talented physician with a track record of success to work with the VP/Medical Affairs Lead COPD and Global Medical Affairs Leads for Trelegy and Anoro contribute to global medical affairs, evidence generation and launch optimization strategies across major markets including China and Japan.
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 Leads (GMALs) COPD.
• Work closely with GMALs 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.
Key responsibilities:
• 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 (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, 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 GMALs in providing medical governance oversight for the asset, including the management of product-related issues/ crises.
Qualifications
• Medical degree
• 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 (preferred)
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.
