Scientific Director - Benlysta Medical Affairs, Open to flexibility
Scientific Director- Benlysta Global Medical Affairs - Immuno-Inflammation and Future Pipeline (II/FP), Open to flexibility
Benlysta is currently the only medicine specifically developed and approved for systemic lupus erythematosus (SLE). Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. We now have some fantastic opportunities to join this department in the UK and US at Scientific Director level.
This is an exciting opportunity to work with a high-performing global medical affairs team who are addressing the numerous medical affairs needs of a medically significant first in class for lupus globally marketed medicine, Benlysta. We are looking for an above average high-functioning, self-starting accomplished medical affairs scientist, with a track record of success, and independent working to partner, guide and assist global local operating colleagues as well as lead the successful delivery of Benlysta global medical affairs projects.
Responsibilities and activities can include and not be limited to the following in partnership with Benlysta Global Medical Affairs Team, the Global Medical Affairs Leader (GMAL), LOCs, and other stakeholders internal and external.
- Contributing to the Global Medical Affairs Plan and Integrated Evidence Plan for Benlysta.
- Leading and/or contributing to above-country insight generation activities including, for examples, Advisory Boards; scientific workshops, and others
- Leading and/or contributing to above-country educational activities including, for example, symposia, webinars, etc.
- Partnering with commercial colleagues to develop brand campaigns and support launches.
- Developing and approving promotional, non-promotional and training materials.
- Delivering the evidence needs of that asset in partnership with:
- Supporting the Integrated Evidence Team;
- Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need
- Driving excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
- Supports the GMAL in gathering medical insights from the Franchise LOCs and external stakeholders (HCP's, Patients, Payors and Regulators) to shape life cycle management including 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 governance 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).
- Supports 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 GMAL and team in providing medical governance oversight for the asset, including the management of product-related issues/ crises.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Thank you for your interest in this opportunity.
Application closing date: 1st December 2018
This role is only available for a 2019 start.
- PharmD, PhD or equivalent
- Exceptional written and verbal communication skills.
- Strong critical thinking strategically and tactically.
- 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
- Established ability to of self-motivated ownership and accountability for projects, move them forward, and deliver with minimal supervision
- Significant experience in Medical Affairs including understanding of launch support requirements.
- Recognised ability to be flexible in a changing landscape
- Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements.
- Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
- Significant experience in Immunology Medical Affairs
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