The Medical Affairs Lead will actively contribute to reaching the companies goals by giving strategic medical input into the product development, planning and executing medical-scientific activities. Together with its team the function establishes a successful and sustainable liaison with external medical community and life cycle management.
Under general supervision of the Medical LOC Head, defines the country medical strategy of the assigned indication, ensures its reflection in cascaded medical affairs plan and is in charge for the successful activities of subordinates and team members.
• Medical therapeutic area lead for haematology
• Build and implement the medical strategy for the therapeutic area and it’s products
• Leads a medical advisor team within the therapeutic area
• Assemble and manage key opinion leader advisory groups for Oncology products.
• Act as a medical resource in Oncology to GSK and particularly to the clinical research (protocol and Clinical Report Form writing, adverse events, discussions with investigators, internal meetings) and Market Access department.
• Expert in the therapeutic area and provide input into product development teams and for launched products into marketing teams
• Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
• Establish ongoing liaison with key opinion leaders, government officials, senior regulatory authorities
• Ensures that significant developments in the field are identified and monitored.
Why You?Basic qualifications:
• Scientific degree/PhD (medical doctor preferred)
• 7 years of relevant working experience in oncology medical affairs
• State of the art knowledge in Haematology
• Extensive knowledge of all aspects of drug development, GCP and regulations
• Successful experience working in a matrix team environment to deliver solutions without
directly 'owning' all the staff or solution delivery functions
• Experience in pharmaceutical industry
• Adequate and sound knowledge in pharmaceutical development
• Strong collaboration, documentation and presentation skills, demonstrated superior verbal, written, and presentation skills with all levels of staff
• 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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