Associate Director, Clinical Scientist – Neuroimmunology

AstraZeneca • Cambridge, MA

3d • $142,000 - $213,000

About The Position

The Associate Director, Clinical Scientist supports AstraZeneca’s Neuroimmunology portfolio, beginning with multiple sclerosis and expanding to other immune-mediated neurological indications and modalities. As part of a multidisciplinary study team, the role partners closely with the Study Physician and fellow clinical scientists to monitor, track, and analyze participant data throughout the study lifecycle, and contributes to clinical documents and day-to-day work that keep studies inspection-ready and support sound decisions.

The position collaborates with Clinical Operations, Data Management, Biostatistics, Clinical Pharmacology (DMPK), Pharmacovigilance, Translational Medicine, and Regulatory. It offers the opportunity to develop clinical-science and clinical-development skills in a mentoring team working on advanced cell therapies and immunotherapies. The role reports to the Global Clinical Head, Neuroimmunology, or their designee. Medical-judgment questions are escalated to the Study Physician, and program-strategy items to the Global Clinical Program Lead.

Requirements

• Master’s degree in a life-sciences or related field and at least 2 years of relevant clinical or scientific research experience, or an advanced degree (such as 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, curiosity about patterns in complex clinical data, and meticulous attention to detail.
• Ability to collaborate in a fast-paced matrix environment and reliably follow complex direction.
• Sound judgment in handling confidential, regulated information; high ethical standards; initiative; and a collaborative, trustworthy team orientation.

Nice To Haves

• Industry clinical-development experience.
• Experience in, or strong interest in, cellular therapies, CAR-T, and/or T-cell-engager trials.
• Experience in neurology, multiple sclerosis, or another immune-mediated disease.
• Experience with Phase 1 and Phase 2 clinical trials.
• Familiarity with data-analysis and programming tools such as R, SAS, or Python, and clinical-review tools such as Medidata Rave or J-Review.
• Ability to travel nationally and internationally as needed.

Responsibilities

• Support ongoing review, tracking, and analysis of clinical-trial participant data, including patient profiles, data listings, summary tables, laboratory and other safety parameters, and coded terms for consistency and completeness.
• Contribute to interpretation of emerging clinical data and identification of clinically meaningful findings, trends, and questions for study-team evaluation.
• Assist with routine safety and efficacy data review, flag events of interest or data trends for further investigation, and prepare preliminary summaries for the study team.
• Contribute to query generation, coding reconciliation for adverse events and serious adverse events, medical and surgical history, and concomitant medications, and edit-check refinement with Data Management and Biostatistics.
• Support database-lock readiness activities and cross-checks.
• Contribute to authoring and reviewing clinical documents, including protocols and amendments, protocol clarification letters, investigator’s brochures, informed consent forms, case report forms and eCRF completion guidelines, medical monitoring plans, charters, laboratory 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, including data review and presentation preparation.
• Support operational integrity of multiple-sclerosis assessments, including central MRI charter adherence, EDSS scoring quality and rater reliability, and completeness of relapse-adjudication packages.
• Perform analyses and generate scientific slide decks from clinical, translational, and other datasets, and help communicate clear overviews of trial data.
• Review and synthesize scientific literature and competitive intelligence to support study and program strategy, and contribute to abstracts, posters, manuscripts, and conference materials.
• Support review of statistical analysis plans and table, listing, and figure shells to ensure traceability from protocol to outputs.
• 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 with Clinical Operations and vendors, document rationale, and appropriately escalate clinical-impact items.
• Maintain up-to-date knowledge of relevant science, GCP, and regulatory guidance.

Benefits

• Eligibility for short-term incentive bonuses.
• Equity-based awards for salaried roles.
• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior