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GMA Oncology Franchise Medical Director Niraparib

GSK
Job LocationBrentford
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Oct 21 2019Are you interested in a highly visible medical affairs role that allows you to shape and execute the brand medical strategy, for a key asset while engaging with a broad range of highly specialized experts If so, this Global Medical Affairs Medical Director role could be an ideal opportunity to explore. GSK’s Research & Development Pipeline in Oncology:GSK Oncology is committed to the discovery and development of new and potentially life-changing therapies for patients with cancer. Our vision is for people with cancer to not only to live, but to live well, because we are delivering innovative and transformational medicines. GSK’s approach to oncology is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics, and most recently in genetic medicine, thanks to our recent acquisition of Tesaro, Inc. and a new global alliance with Merck KGaA. (also known as EMD Serono in the U.S.) Global strategic alliance with Merck KGaA (known EMD Serono in the U.S.)

  • In February 2019, GSK and Merck KGaA announced a global strategic alliance to jointly develop and commercialise M7824 (bintrafusp alfa*), an investigational bifunctional fusion protein immunotherapy currently in clinical development for multiple difficult-to-treat cancers. This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).It has the potential of offering new ways to fight difficult-to-treat cancers beyond the established PD-1/PD-L1 class as a single agent or for use in combination with other therapies.With this alliance, we can have a leadership position in this new class of immunotherapies, specifically leveraging TGF-ß biology. For GSK, this is a further step to strengthen our pharmaceuticals pipeline, along with our recent acquisition of TESARO, Inc., an oncology-focused company based in Waltham, Massachusetts in January 2019.
    • Acquisition of Tesaro, Inc.
  • GSK’s acquisition of Tesaro, Inc. an oncology-focused company based in Waltham, Massachusetts, significantly strengthens our pharmaceuticals business through accelerating of GSK’s pipeline and commercial capability in oncology.TESARO has a major marketed oncology product, Zejula (niraparib), an oral poly ADP ribose polymerase (PARP) inhibitor currently approved in the US and Europe as a maintenance treatment for adult patients with recurrent ovarian cancer who responded on platinum-based chemotherapy.PARP inhibitors are transforming the treatment of ovarian cancer, with Zejula demonstrating marked clinical benefit in patients with or without a germline mutation in a BRCA gene. GSK also believes that PARP inhibitors offer significant opportunities for use in the treatment of multiple cancer types, therefore niraparib is also being investigated for use as a possible treatment in lung, breast, and prostate cancer, both as a monotherapy and in combination with other medicines, including with TESARO’s own anti-PD-1 antibody (dostarlimab, formerly known as TSR-042).In addition to niraparib and dostarlimab, TESARO has several other oncology assets in its pipeline, including antibodies directed against TIM-3 and LAG-3 targets.
    • R&D Collaboration with Merck’s Keytruda
  • GSK’s experimental drug GSK095 is designed to work in tandem with checkpoint inhibiting medicines in the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a preclinical trial of a related GSK drug suggest that the combo holds promise in treating pancreatic cancer—so much so that, in late 2018, we have launched a Phase I of the drug in combination with Merck’s blockbuster PD1 checkpoint inhibitor, Keytruda.
    • Details about our portfolio can be found here: GSK 2018 Annual ReportGSK Product PipelinePosition SummaryWorking independently, the Medical Director is capable of fully leading designated aspects of the Medical Affairs strategic planning process and its implementation on behalf of the Global Medical Affairs Leader (GMAL) and in collaboration with her/his peers and other functions in the medical affairs team. The scope of the role therefore mirrors parts of the scope of the GMAL role, to whom she/he is accountable. This may include the following activities:
  • Plays an integral role in building/optimising the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/indication(s).
  • Works closely with the Physician Project Leader (PPL) and Medicine Development Leader (MDL) to optimise development plans.
  • Drives delivery of designated above-country elements of the MAP, e.g. Advisory Boards, Symposia, Educational Events.
  • Partners with commercial colleagues to optimise brand strategy, campaigns and launches in the Franchise Local Operating Companies (LOCs).
  • Leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).
  • Drives the development and/or approval of promotional, educational, training and other materials and responses.
  • Drives the congress planning and coordination from a brand perspective, including pre- and post-congress deliverables
  • Drives the scientific training coordination and execution from a brand perspective, including material development and/or approval
  • Delivers the evidence needs for that asset on behalf of the GMAL in partnership with R&D:
  • Drives the efficient working of the Integrated Evidence Team; ensuring insights from Franchise LOCs are integrated appropriately to inform the IEP.
  • Reviews local GSK-sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D experts.
  • Accountable for the development of assigned Franchise study protocols.
  • Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
  • Deputizes regularly for the GMAL as required.
    • Key responsibilities* Gathers medical insights from the Franchise Local Operating Companies (LOCs) and external stakeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and global medical affairs plans and strategy.</li

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