DIRECTOR CLINICAL SCIENTIST - B7-H4

Site Name.
UK - Hertfordshire - Stevenage, GSK HQ, Upper Providence, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53, Zug House Posted Date.
Dec Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you! As Clinical Development (Oncology) Director, you will be responsible for leading GSK medium and long-term oncology development strategies for GSK’s oncology pipeline.
You will work closely with the Global Oncology Research and Development and Medical Affairs to ensure that the oncology clinical team have the highest quality capabilities and expertise.
You will also ensure the optimal launch of new products and appropriate optimal patient use of currently available GSK Medicines through leadership and collaboration.
Responsibilities.
• Provide 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.
• Author the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Board (PRB), incorporates any changes suggested post-governance meetings • Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in blinded review of data packages intended for IDMCs • Lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfil regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead (PPL) and other Study Team members/stakeholders, as appropriate).
• Engage and influence a diverse scientific community of internal and external experts, including collaborations.
• Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study • Lead and contribute 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 • 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 • Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP • Provide 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) • Contribute to all regulatory reporting requirements (e.
., DSUR, INDSRs, etc.) and ensure prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.
• Responsible for ensuring the Go/No-Go criteria have been set for the study • Presents the scientific rationale and study design at Investigator Meetings and responds to • Scientific questions arising from sites during study conduct Basic Qualifications Include.
• Experience in pharmaceutical/biotechnology industry or related clinical experience • Experience & understanding of clinical development from early stage through to regulatory submission and market support.
• Matrix management experience • Experience with data review/interpretation, study design, protocol authoring, amendments • Experience authoring and/or collaborating on IBs, clinical study proposals, informed consent and study manuals • Experience presenting or preparing PRF’s – protocol review forums • Excellent leadership skills • Clinical development plan management experience Preferred Qualifications include.
• Advanced degree (e.
.
MS, PhD, PharmD) • Clinical development experience across all phases of development (I-IV).
• Oncology or immuno-oncology experience • Knowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory • Interactions/approvals and active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetings Job Description.
Director, Clinical Scientist Feb • Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes.
• Thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
• Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change *LI-GSK Why GSK? Uniting science, technology and talent to get ahead of disease together.
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