Director, Clinical Scientist - Neuroimmunology

AstraZeneca•Cambridge, MA

8d•$203,000 - $305,000•Onsite

About The Position

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.

Requirements

Advanced scientific or clinical degree (PhD, PharmD, MD, or equivalent) in a life-sciences or related field.
At least 6 years' clinical-development experience, with strong hands-on study execution and medical and data review.
Neurology or multiple sclerosis experience preferred.
Proven experience designing and delivering clinical trials, including protocol and ICF development, medical monitoring and safety data review, IB and DSUR contributions, clinical data review and interpretation, and CSR authorship.
Deep working knowledge of ICH-GCP and global regulatory expectations across Phase 1 and 2, with Phase 3 a plus, and experience contributing clinical-science content to regulatory interactions and submissions such as IND/CTA.
Proficiency with clinical databases, listings review, and coding, and effective collaboration with Biostatistics, Data Management, and Pharmacovigilance.
Command of clinical-trial methodology and statistical concepts sufficient to support data-driven decision-making.
Demonstrated cross-functional collaboration, the ability to influence internal and external stakeholders, learning agility, and solution-focused problem-solving.
Attention to detail, an ownership mindset, and a track record of delivering results.

Nice To Haves

Direct clinical-development experience in CAR-T or other engineered cell therapies, and/or T-cell engagers, across autoimmune or inflammatory indications, including operational constraints such as chain-of-identity/control and vein-to-vein logistics, and CMC-clinical interfaces.
Understanding of end-to-end cell-therapy development across research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, and commercial.
Experience mentoring or providing work direction to junior scientists.
External credibility with investigators, academic partners, consortia, and CROs.
Data-analysis and programming familiarity (for example R, SAS, Python) and clinical-review tools (for example Medidata Rave, J-Review).
Ability to travel nationally and internationally.

Responsibilities

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.
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.
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.
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.
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.
Draft and review clinical sections of regulatory documents and responses, including HA interactions, briefing books, IND and annual reports, PIPs, and safety updates, ensuring SLMOP-driven surveillance outputs are reflected accurately and aligned with GCP, ICH, FDA, and EMA expectations.
Lead development, review, and quality of abstracts, posters, manuscripts, and scientific presentations, ensuring data coherence across disclosures.
Provide study-specific onboarding and support for Study Physicians and coach junior Clinical Scientists on study background, systems, oversight processes, and effective communication and expectations.
Track key developments in the MS, neuroimmunology, and cell-therapy literature and competitive landscape, and propose pragmatic protocol or analysis optimizations that improve probability of success without destabilizing operations.