Medical Advisor, Dostarlimab
Position: Full-Time Regular
Open date: Sep 26, 2019
Functional area: Medical and Clinical
Required degrees: Medical Doctor
2 roles are available. One to focus on Zejula (Niraparib) an orally active small molecule PARP inhibitor to treat ovarian cancer and the other focusing on Dostarlimab an anti-PD-1 therapy to treat endometrial cancer.
Medical Advisor is an office-based, field directed medical professional who uses medical knowledge and customer insights to develop the country medical affairs plan, and engage in peer-to-peer communication & provide cutting edge scientific information to external stakeholders and medical advice to internal stakeholders such as market access, commercial & clinical colleagues. Under general supervision of the Medical Affairs Lead, develops and manages country medical strategy of the assigned product/indications. Medical Advisor drives the strategic and tactical execution of the corresponding medical affairs plan. Works in close collaboration with the Medical Affairs Lead, marketing and access counterparts as well as regulatory and other local / regional stakeholders for the products/ indications.
• Development of Medical Affairs Plan respecting the global strategy but outlining the specifics for the country e.g. different standard of care, reimbursement timeline
• Planning and implementation of local Medical Affairs activities within the agreed timelines and budgets applying the knowledge of GSK and competitor products and therapeutic options and understanding the disease environment
• Active knowledge acquisition in the therapeutic area. Ability to interpret the results of studies in line with EvidenceBasedMedicine principles
• Establishing, maintaining and comprehensive management of medical / scientific relations with external experts, healthcare institutions, scientific societies, patient organizations, government officials and senior regulatory authorities
• Plans and executes Advisory boards/Scientific Engagement Workshops, contributes to GSK sponsored meetings, preparing and delivering scientific presentations in the field of therapeutic area and GSK products for external audiences, giving own lecture as relevant active participant in symposia and congresses
• Active acquisition of knowledge from the external environment on current standards and guidelines as well as GSK products and anticipated changes in this field
• Publications development
• Collaboration with the Marketing Department in the development of promotional and educational materials in line with the Pharmaceutical Law, GSK Code of Practice and given guidelines
• Support of clinical research (protocol and CRF writing, adverse events, discussions with investigators, internal meetings) and Market Access department
• Collaboration with the global team for scientific exchange and activity in the therapeutic area
• Provides medical and scientific training to internal customers
• Scientific degree (molecular biology or medical doctor)
• 3 years of relevant working experience in oncology medical affairs
• Extensive knowledge of all aspects of drug development, GCP and regulations
• Successful experience working in a matrix team environment
• Understanding of marketing principles and strategies
• Demonstrated customer focus, integrity and relationship building skills, consensus building skills
• Excellency in written and spoken English
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 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 as 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-β 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 treatment for adult patients with recurrent ovarian cancer. PARP inhibitors are transforming the treatment of ovarian cancer, notably demonstrating marked clinical benefit in patients with or without germline mutations in a BRCA gene (gBRCA).GSK also believes that PARP inhibitors offer significant opportunities for use in the treatment of multiple cancer types, therefore Zejula is also being investigated for use as a possible treatment in lung, breast, and prostate cancers, both as a monotherapy and in combination with other medicines, including TESARO's own anti-PD-1 antibody (dostarlimab, formerly known as TSR-042). In addition to Zejula 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."
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