- GlaxoSmithKline PLC
- $152,300.00 -152,300.00/year*
Healthcare - Physician
759 Cornell Ave
Are you interested in a highly visible global medical affairs role that allows you to have an integral role in building/optimising the Global Medical Affairs Plan reporting to a global leader? If so, this Medical Affairs 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-? 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 Report GSK Product Pipeline
For more information, please visit:
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.
Working 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:
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. Leads Advisory Board design and discussion ensuring compliance with SE governance and documentation requirements (Approval Templates; GLASSES etc). Leads Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements (Approval Templates; GLASSES etc). Inputs to the design and delivery of phase IIIb/IV studies and EAPs, including post-approval commitments, coordinating with relevant R&D technical experts e.g. Global Health Organization and Epidemiology. Responsible for the review of local GSK-sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D, safety, biostats, and other experts. Facilitates preparation for the aPIB review / Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across Franchises/Franchise LOCs. Plays an integral role in the development and approval of brand strategy, and promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc). Develops/reviews publications/abstracts/posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained. Supports the GMAL in communicating effectively the clinical and market access data for their asset to the Franchise LOCs; ensures a robust understanding of risk: benefit. Enhances local tactical plans and shares best practices to support Launch Excellence. Supports the GMAL in providing medical governance oversight for the asset, including management of product-related issues with potential impact on patient safety, and medical budget management. Responsible for leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s). Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
Additional Responsibilities* High level of responsibility for successful delivery of critical projects and processes. Responsible for building and driving the Global Medical Affairs strategy and IEP for the asset/indication(s), on behalf of the GMAL. Building credibility through the richness of her/his content expertise. Responsible for successful delivery of Global Integrated Medical Affairs Plans (MAPs), Medical (Pre)Launch Plans, and Integrated Evidence Plans (IEP) for the relevant asset/indication(s) in accordance with GSK and statutory requirements. Provides input into development plans. Responsible for driving internal scientific training coordination and execution from an asset perspective, including material development and/or approval in accordance with GSK and statutory requirements/ Responsible for driving excellence in external engagement - building credibility with, and insights through, a strong external network. Ensures appropriate medical governance including the management of product-related issues with potential impact on patient safety. Responsible for driving the development and/or for the approval of promotional, educational, training and other materials and responses in accordance with GSK and statutory requirements. Responsible for driving the congress planning and coordination from a brand perspective, including pre- and post-congress deliverables. Deputizes regularly for the GMAL as required.
* as delegated by the GMAL and in alignment with peers
We are looking for professionals with these required skills to achieve our goals: Medical Doctor-Board Certification (or equivalent credentials) Industry and/or clinical experience in the oncology therapeutic area Significant disease and therapeutic area knowledge. Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements. Ability to develop, design and implement Phase IIIb/IV studies. Significant experience in Global Medical Affairs and life cycle management, including launch support requirements. Robust understanding of promotional codes/regulations; previous involvement in review and approval processes. Highly developed leadership, networking, communication, intercultural communication skills and influencing skills to work effectively in a complex matrix and global environment. Demonstrated ability to build strong internal and external networks. Ability to work across time zones and to travel
If you have the following characteristics, it would be a plus: Extensive clinical and industry experience (Gyn)Oncology
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation.
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Associated topics: ancmg, aoa, cancer, hem onc, hematology, lah, oncology, physician md, physician md do, thedacare
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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