Medical Director- Oncology Clinical Development-ICOS
The Medical Director will be an integral part of the Clinical Team within the GSK Immuno-Oncology (IO) Discovery Performance Unit (DPU). The IO-DPU focuses on the pre-clinical- and early clinical development of novel, preferentially first-in-class transformational drug-candidates that affect the immune system to maximize tumor control and result in increased survival of patients. Assets includes ICOS agonist, OX40 agonist, TLR-4 agonist and other IO agents.
The Medical Director will be responsible for all aspects related to the clinical development of either a single or combinations.
In this role, the Medical Director will belong to multi-functional drug development team(s) and will work closely with scientists, statisticians, and other physicians in the discovery- and translational-medicine groups.
The Medical Director will be reporting within and managing clinical development team(s) consisting of physicians, and clinical scientists. The candidate will provide critical clinical guidance from the selection of a drug candidate to the initial proof-of-concept in clinical trial(s) passing through phase I, II, and pivotal phase IIII including regulatory filing and registration. The Medical Director will contribute scientific and medical expertise as well as experience in clinical trial design insights to the activities of the Clinical Team.
• Strategic leadership for clinical development plans
• Management of critical resources and clinical project timelines
• Preparation, design, and/or review of clinical documents, e.g. protocols, investigator's brochures, electronic case report form (e-CRF) design
• Immun-oncology Clinical trial design and optimization
• Data optimization and eCRF creation, optimization, and finalization.
• Participation in interpretation of data analyses of clinical trial results and developing clinical trial reports
• Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.)
• Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators
• Participation in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits
• Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
• Review adverse event (AE)/ serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with GSK safety /the CRO safety team to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs
• Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources
• Represent GSK-Oncology at scientific meetings and presentations
• Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content
• Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
• Develop and manage relationships with key opinion leaders for clinical programs
Please use the cover letter to highlight how you meet the qualifications and competencies for the role. Your CV along with your cover letter will be used to assess your application.
•• M.D. or M.D./Ph.D.
• Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred
• At least 5 years pharmaceutical or relevant scientific/medical/clinical experience
• Experience or interest in experimental cancer-therapeutics especially immune-oncology is an advantageous
• Early clinical trial (Phase 1 and 2) or late (phase 3) experience in pharmaceutical or biotech industries, or equivalent academic and clinical Oncology experience especially immune-oncology preferred
• Understanding and track record in trial design, conduct, and medical monitoring preferred
• Ability to work proactively and effectively applying creative problem-solving skills
• Excellent strategic planning, organizational and communication skills
• Managerial experience working within or leading high-performance, cross-functional matrix teams
As noted above
GlaxoSmithKline (GSK) is science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK has three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer products. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies.
GSK's powerful combination of skills and resources provides a platform for delivering strong growth and responding quickly to the rapidly changing global healthcare environment. We are focused around three core business: Consumer Healthcare, Pharmaceuticals and Vaccines. With global commercial infrastructure and functional support, international supply networks and innovative R&D, GSK has a global commercial presence in more than 150 markets, a network of 84 manufacturing sites in 36 countries and large R&D centers in the UK, US, Belgium and China. The United States is the single largest market for GlaxoSmithKline.
A more integrated, competitive Pharmaceuticals business is foreseen by significantly strengthening the existing partnership between R&D and commercial. GSK announced its commitment to prioritizing its biggest revenue driver, the pharmaceutical business, recognizing the heart of that business is pharma R&D. Going forward, four key areas will benefit from 80 percent of the R&D budget; respiratory, HIV/infectious diseases, immuno-inflammation and oncology.
Leading GSK in this new era is Emma Walmsley who was appointed CEO in 2017. Several significant leadership appointments including Hal Barron, Chief Scientific Officer and President of R&D, and Luke Miels, President, Global Pharmaceuticals have been made. Both are highly respected leaders with a track record of bringing new medicines to market.
In Oncology, we are focused on delivering transformational therapies that can lengthen the lives of patients with cancer. In 2017, we made significant progress in our emerging portfolio of next generation therapies in the areas of immuno-oncology, cell therapy and epigenetics.
Our 2857916 monoclonal antibody against BCMA has the potential to target a number of tumor types, including relapsed and refractory multiple myeloma. Promising early results suggest a highly competitive profile compared with existing approved treatments for multiple myeloma. It has been granted European PRIME and FDA breakthrough status, potentially resulting in faster review by the regulatory authorities when it is filed.
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