Associate Director, Clinical Scientist – Neuroimmunology Full-time

Clinical Scientist, Neuroimmunology

Are you a scientist with a passion for clinical drug development and a strong scientific foundation, who wants to learn the craft of clinical science on breakthrough cell and immunotherapies for immune-mediated neurological disease? Do you have sharp analytical instincts, a search-and-find mindset in complex clinical data, and the collaborative temperament to thrive in a cross-functional team? If so, we invite you to join us.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that discovers, develops and commercializes prescription medicines for some of the world's most serious diseases. Within Immunology R&D, our Neuroimmunology team is building a world-class capability to accelerate the delivery of transformative cell therapies and immunotherapies for patients with immune-mediated neurological disease. AZ is a place built on courage, curiosity and collaboration, and we make bold decisions driven by patient outcomes.

The Associate Director, Clinical Scientist is a member of a multi-disciplinary study team, working in close partnership with the Study Physician and fellow clinical scientists. You will provide clinical-scientific support to help monitor, track, and analyze participant data across the study lifecycle, and contribute to the 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 is an excellent opportunity to build clinical-development craft on advanced modalities within a supportive, mentoring team. You will report to the Global Clinical Head, Neuroimmunology, or their designee, and work closely with the Study Physician, fellow clinical scientists, and the Global Clinical Program Lead (GCPL), who leads the program's clinical development strategy. Medical-judgement questions are escalated to the Study Physician, and program-strategy items to the GCPL.

Typical Accountabilities

Clinical data review and monitoring

• Support ongoing review, tracking, and analysis of clinical-trial participant data, reviewing patient profiles, data listings, summary tables, laboratory and other 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 by the study team.
• Assist with routine safety and efficacy data review, help 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, and support database-lock readiness activities and cross-checks.

Documents and operational translation

• Contribute to authoring and review of clinical documents in alignment with the clinical development plan, 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), including data review and presentation preparation.

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, in collaboration with the study team and Study Physician.

Analysis, literature, and communication

• Perform analyses and generate scientific slide decks based on 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 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.

Essential Qualifications and Skills

• Master's degree in a life-sciences or related field with minimum 2 years relevant clinical or scientific research experience, or an advanced degree (for example PhD, PharmD, MD, MPH, MSN/RN, or equivalent) in a life-sciences or related field.
• Industry clinical-development experience is a plus but not required at this level.
• 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 the ability to follow complex direction reliably.
• Sound judgment in handling confidential, regulated information, high ethical standards, initiative, and a collaborative, trustworthy team orientation.

Desirable 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 (for example R, SAS, Python) and clinical-review tools (for example Medidata Rave, J-Review).
• Ability to travel nationally and internationally as needed.

The annual base pay for this position ranges from $142K to $213K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.