Associate Director, Clinical Scientist – Neuroimmunology
About the role
AstraZeneca is seeking a Clinical Scientist, Neuroimmunology to support our neuroimmunology portfolio, starting in multiple sclerosis and extending to additional immune-mediated indications and modalities. This role is an excellent opportunity to build clinical-development craft on advanced modalities within a supportive, mentoring team. You will provide clinical-scientific support to monitor, track, and analyze participant data across the study lifecycle and contribute to documents and day-to-day clinical-science work that keep studies inspection-ready and decision-enabling.
You will collaborate with all groups involved in clinical development, including Clinical Operations, Data Management, Biostatistics, Clinical Pharmacology (DMPK), Pharmacovigilance, Translational Medicine, and Regulatory. This role reports to the Global Clinical Head, Neuroimmunology, or their designee, and works closely with the Study Physician, fellow clinical scientists, and the Global Clinical Program Lead (GCPL).
Responsibilities
- Clinical data review and monitoring
- Support ongoing review, tracking, and analysis of clinical-trial participant data, including patient profiles, data listings, summary tables, laboratory and safety parameters, and coded terms for consistency and completeness.
- Contribute to the interpretation of emerging clinical data and identification of clinically meaningful findings, trends, and questions for further evaluation.
- Assist with routine safety and efficacy data review, flag events of interest or data trends needing further investigation, and prepare preliminary summaries for the study team.
- Contribute to query generation, coding reconciliation (AE/SAE, medical/surgical history, concomitant medications), and edit-check refinement in collaboration with Data Management and Biostatistics.
- Support database-lock readiness activities and cross-checks.
- Documents and operational translation
- Contribute to authoring and review of clinical documents such as protocols and amendments, protocol clarification letters, IBs, ICFs, CRFs and eCRF completion guidelines, medical monitoring plans, charters, lab and pharmacy manuals, and training materials.
- Help translate protocol intent into operational deliverables and support maintenance of the protocol clarification log.
- Contribute to preparation and review of safety narratives, regulatory-submission sections, responses to health-authority requests, and materials for safety review committees (SRC, IDMC, DMC).
- Endpoint integrity (MS-specific)
- Support the operational integrity of MS assessments, such as central MRI charter adherence, EDSS scoring quality and rater reliability, and relapse-adjudication package completeness.
- Analysis, literature, and communication
- Perform analyses and generate scientific slide decks based on clinical, translational, and other datasets.
- Review and synthesize scientific literature and competitive intelligence to support study and program strategy.
- Contribute to abstracts, posters, manuscripts, and conference materials.
- Support the review of statistical analysis plans and table, listing, and figure shells for traceability from protocol to outputs.
- Collaboration and deviations
- Serve as a supporting point of contact for routine scientific and procedural questions from sites and CROs, draft clarifications for team review, and support site initiation visits and investigator meetings.
- Assist with deviation trending and CAPAs in partnership with Clinical Operations and vendors, documenting rationale and escalating clinical-impact items appropriately.
- Maintain up-to-date knowledge of relevant science, GCP, and regulatory guidance.
Requirements
- Master's degree in a life-sciences or related field with minimum 2 years relevant clinical or scientific research experience, or an advanced degree (e.g., PhD, PharmD, MD, MPH, MSN/RN, or equivalent) in a life-sciences or related field.
- Understanding of clinical-trial design, statistical concepts, and the connection between nonclinical and clinical data.
- Familiarity with ICH, GCP, and relevant regulatory requirements.
- Strong analytical skills and a genuine curiosity for patterns in complex clinical data, with meticulous attention to detail.
- Ability to work collaboratively in a fast-paced matrix environment and follow complex direction reliably.
- Sound judgment in handling confidential, regulated information, high ethical standards, initiative, and a collaborative, trustworthy team orientation.
Skills
- Experience in, or strong interest in, cellular therapies, CAR-T, and/or T-cell-engager trials.
- Experience in neurology, multiple sclerosis, or other immune-mediated disease.
- Experience with Phase 1 and Phase 2 clinical trials.
- Data-analysis and programming familiarity (e.g., R, SAS, Python) and clinical-review tools (e.g., Medidata Rave, J-Review).
- Ability to travel nationally and internationally as needed.
Pay
The annual base pay for this position ranges from $142K to $213K. Positions offer eligibility for various incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.
Benefits
- Qualified retirement programs.
- Paid time off (vacation, holiday, and leaves).
- Health, dental, and vision coverage in accordance with the terms of the applicable plans.