Director, Clinical Scientist - Neuroimmunology

Responsibilities

• ● Are you an experienced clinical scientist who wants to help bring transformative cell and immunotherapies to patients with serious immune-mediated neurological disease Do you combine deep hands-on study execution, from medical and data review to endpoint integrity and document authorship, with the judgment to run the clinical-science engine of a trial with minimal escalation Do you thrive where strategy meets day-to-day ownership, and enjoy mentoring more junior scientists If so, we invite you to join us. We are seeking a Director, Clinical Scientist, Neuroimmunology to drive study-level clinical science across our neuroimmunology portfolio, starting in multiple sclerosis and extending to additional immune-mediated neurologic indications.
• ● The Director, Clinical Scientist leads the day-to-day clinical-science engine of one or more studies, working synergistically with the Study Physician as the expert on the medical-scientific and operational-science aspects of our compounds and their development. You will report to the Global Clinical Head, Neuroimmunology, or their designee, and partnering closely with the Study Physician and the Global Clinical Program Lead (GCPL), you will translate the program's clinical development plan into inspection-ready, decision-enabling studies. You will own document cycles, continuous medical and data review, endpoint integrity, and the site and CRO clinical-science interface, so that routine clinical-science work is handled at the study level. You will operate in compliance with GCP, AZ quality systems, and relevant regulatory guidelines, and will help develop and mentor junior clinical scientists. The GCPL leads the program's clinical development strategy and holds program-level accountability. Medical judgement, benefit-risk, and final medical sign-off sit with the Study Physician ; program strategy and cross-study trade-offs are set with the GCPL. Typical Accountabilities
• ● Document ownership and operational translation
• ● Act as lead author and reviewer for study-level documents in alignment with the clinical development plan, including protocols and amendments, IB updates, ICFs, clinical and scientific training materials, medical monitoring plans, and charters such as MRI central read and relapse adjudication. Manage version control and cross-document consistency.
• ● Translate protocol intent into operational deliverables such as CRFs and eCRF completion guidelines, lab and pharmacy manuals, and rater guidance. Own the protocol clarification log and ensure site workflows support endpoint quality and data timeliness.
• ● Ensure clinical study protocols and associated documents align with the clinical development plan and connect trial data to the Target Product Profile.
• ● Ongoing medical and data review and safety-surveillance partnership
• ● Perform routine, independent review of patient profiles, listings, coded terms, and narratives. Run trend checks across safety, efficacy, and protocol compliance, and maintain issue , action, and decision logs, driving timely closure.
• ● Contribute to the interpretation of emerging clinical data and identification of clinically meaningful findings, trends, and questions for further evaluation by the study team.
• ● Own the day-to-day execution of study-level medical oversight as defined in the Study-Level Medical Oversight Plan (SLMOP), ensuring participant-level and aggregate reviews occur at the specified frequencies, with outcomes documented and filed to the TMF per SOP and SLMOP timelines.
• ● Partner with Pharmacovigilance on AE and SAE triage, reconciliation, and timely narrative drafting. Conduct AESI reviews and trending (these include CRS, neurotoxicity/ICANS, infections, IEC-HS, IEC-associated colitis, and new malignancies), prepare SRC, IDMC, and DMC safety packets, and flag emerging signals promptly with proposed next steps, bringing medical-judgement items to the Study Physician.
• ● Perform real-time participant-level eligibility reviews during screening, and drive query generation, coding reconciliation, and edit-check refinement with Data Management and Biostatistics.
• ● Endpoint integrity (MS-specific)
• ● Own the operational integrity of MS assessments, including MRI central-read charter adherence, EDSS scoring accuracy and FSS concordance, and relapse-adjudication package completeness. Monitor inter-rater reliability and vendor performance, and drive rater and vendor CAPAs where needed.
• ● Data readiness, SAP/TLF alignment, and decision enablement
• ● Lead the query and data-cleaning strategy to hit LPLV, interim, and database-lock milestones with inspection-ready documentation.
• ● Ensure traceability from protocol to SAP and TLF shells, review analysis populations, estimands , and endpoints, and validate mock outputs for decision quality.
• ● Build clear, integrated readouts across safety, efficacy, PK/PD, biomarkers, and operations, with options and recommendations for governance, and maintain decision and assumption logs.
• ● External interface, regulatory support, and disclosures
• ● Serve as first-line clinical and scientific responder for routine questions from sites and CROs, providing consistent, timely clarifications, support site initiation visits and investigator meetings. Lead root-cause analysis and CAPAs with Clinical Operations and vendors.