Reference #: 401036
Site Name: USA - Massachusetts - Waltham, Switzerland - Zug, USA - Pennsylvania - Philadelphia
Posted Date: Jul 17 2024This position will require 2 to 3 days per week onsite presence at our Waltham MA, or Upper Providence (Collegeville) PA or Zug Switzerland location.The Associate Director/Director, Clinical Scientist, Oncology has accountability for providing clinical 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 Associate Director/Director, Clinical Scientist, Oncology will 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 Director and/or the Clinical Development Lead; and other Study Team members/stakeholders, as appropriate). The role is also responsible for designing and executing, in collaboration with the Medical Director, the clinical trial(s) assigned to the project. This role 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 Associate Director/Director, Clinical Scientist, Oncology responsibility includes, but is not limited to:Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the studyLead 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 literatureIntegrate data from internal, and external academic, conference and competitor sourcesUnderstand and support creation and support of competitor landscape, medical need, regulatory strategyAppropriately 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 timeframeDrive/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 documentsDevelop studies in accordance with current GSK policies and proceduresAs appropriate, Lead Clinical Matrix TeamsAccountabilities:Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDPUnderstands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virologyAuthors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetingsEnsures study protocol reflects input from internal and/or external experts/thought leadersiaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possibleProvides 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 objectives (through Medical Monitor/PPL and other stakeholders, as appropriate)Participates in eCRF development and may participate in UATReviews the reporting and analysis plan (RAP) and advises on required outputsParticipates in data review ongoing through study including interim analyses, in-stream data review, etc.Responsible for ensuring the Go/No-Go criteria have been set for the studyPresents the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conductEnsures prompt, quality communications with sites regarding protocol clarification and procedural queriesEnsures completion of medical governance (through a physician on the team) and regulatory reporting at the start to ensure overall safety of the study subjectsInterpretation of study data and scientific content of clinical study reports (CSRs) and regulatory submissionsEnsures CSR and other documents reflect input from internal and/or external experts/thought leaders as appropriateUnderstands and anticipates questions from internal and/or external stakeholders regarding data resultsWorking with the PPL and other stakeholders, clearly communicates results to internal and external stakeholders and regulatorsDrives content of other clinical documents (e.g. Investigator Brochure); regulatory documents input (e.g. DSURs, BRMP, DCSI, Annual Safety Reports, PBRs, etc.)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 meetingsLeads completion/filing of key components of clinical modules (NDA/BLA/MAA, AdCom prep, Scientific Advice) for marketing authorizationPrepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publicationsInputs into the organisation of Advisory boards and other scientific engagement activities.Delivers of end-of-study reports and publication/presentation of resultsReviews/evaluates external collaborations (e.g. SCS, ISS)Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:Bachelor's degree in Life Science or equivalent within2 or more years work experience in Pharma industry or relevant clinical trial experience2 or more years Clinical trial and clini