Director, Clinical Development / Clinical Scientist (Oncology)

GlaxoSmithKline ,
Stevenage, Hertfordshire
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Job Description

Would you like to be part of GSK's exciting oncology clinical development organization? If so, this could be an excellent opportunity to explore. As a Clinical Scientist you will be providing input on clinical and strategic issues that impact the success of our Medicine Development units. This role will give YOU the opportunity to work on key activities to progress YOUR career, these responsibilities include some of the following... The Clinical Scientist has accountability for providing scientific input during protocol development, oversight of study conduct, and 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. The Clinical Scientist will lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfill regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead (PPL) and other Study Team members/stakeholders, as appropriate). The Clinical Scientist is also Responsible for design and execution in collaboration Medical Monitor for multiple-phase studies/ The Clinical Scientist will effectively engage and influence a diverse scientific community of internal and external experts, including collaborations. Further to study/project accountability, the Clinical Scientist may manage other staff within Clinical Sciences. Job Responsibilities: The Clinical Scientist responsibility includes, but is not limited to: * Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study * 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. * Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature * 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) * Ensure the high quality of protocol documents are developed aligned to 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 * 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 * Develop studies in accordance with current GSK policies and procedures * 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 (PRF), incorporates any changes suggested post-governance meetings * Ensures study protocol reflects input from internal and/or external experts/thought leaders * Liaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible * Provides input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM) * Contributes to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.) * Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc. * If Internal Safety Review Committee (ISRC)/IDMC data review is required, participates in, or leads identification of internal or external ISRC/IDMC members, respectively and preparation of charter. Co-ordinates with Medical Monitor/PPL and other Study Team members and stakeholders. * Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objecti

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