Director, Clinical Scientist
Site Name: USA - Pennsylvania - Philadelphia, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park Posted Date: Sep 30 2021 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. 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). 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 Author the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings 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.g., 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 Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors in Life Science degree 10+ years of industry or relevant 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 Clinical development plan management experience Experience authoring and/or collaborating on IBs, clinical study proposals, informed consent and study manuals Experience presenting or preparing PRF's - protocol review forums Immuno Oncology experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience 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 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 Experience in pediatric clinical development Why GSK? 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. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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