Global Medical / Scientific Director - Covid, Open to flexible working
In April we announced a collaboration with Vir Biotechnology to use Vir's monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options for COVID-19. In August, our first patient was dosed in a phase 2/3 study with VIR-7831, a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 patients who are at high risk of hospitalisation. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021.
GSK is also evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic. This includes medicines with potential direct anti-viral activity and those with possible utility in prevention or treatment of secondary complications of COVID-19.
Following this evaluation, we have started a clinical trial to assess whether one of our medicines currently in development - otilimab - can help treat patients who are affected by secondary complications associated with COVID-19. The study began in May 2020.
We have a number of opportunities for a Global Medical/Scientific Director, Medical Affairs, COVID to join our team!
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 GMAL
- 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:
- Supporting the efficient working of the Integrated Evidence Team;
- Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need;
- 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/ crisis.
- Medical Doctor or PharmD / PhD
- Global or above country medical affairs experience
- 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, 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 Infectious Disease or Immunology (preferred)
Priority will be given to those who can start quickly, preferably before November.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
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