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GlaxoSmithKline LLC Clinical Sciences Program Lead (Oncology) in Collegeville, Pennsylvania

Reference #: 280059Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - WalthamPosted Date: Feb 16 2021Would you like to be a clinical science leader and part of GSK's exciting oncology clinical development organization? If so, this could be an excellent leadership opportunity to explore.It's a wonderful time to join our team as wediscover and develop new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research: Cancer Epigenetics, Immuno-Oncology, Oncology Cell Therapy and Synthetic Lethality.Clinical Development at GSK is responsible for the development of the oncology portfolio from First Time In Human (FTIH) clinical trials to Proof-of-Concept studies, and pivotal registration trials.Using your strong leadership, scientific and clinical research background, the Clinical Research/Sciences Leader partners with the physician leader to provide clinical science leadership and input on clinical and strategic issues that impact the progress and success of medicine development for patients.We seek candidates with the following capabilities:* Provide clinical science leadership, input, and oversight of multiple clinical studies either on a late stage asset or across multiple early phase clinical programs.* Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.* Provide input on clinical development plans for Early Development or Medicine Development Teams.* Line manage or mentor other clinical development scientists.* Ensure high quality protocol development aligned with the CDP to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.* Lead or contribute, as appropriate, to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions.* Summarize and provide interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.* Partnering with the Physician Project Lead to ensure patient safety during the study lifecycle, and ensuring that study objectives fulfill regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead and other Study Team members/stakeholders, as appropriate).* Integrate data from internal, and external academic, conference and competitor sources.* Understand and support creation and support of competitor landscape, medical need, regulatory strategy.* Appropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc.* Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan (CDP).* Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.* As appropriate, Lead Clinical Matrix Teams.Accountabilities:* Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP.* Understands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virology.* Authors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum

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