Study Physician, Immunology

AstraZeneca•Cambridge, MA

7d•$203,710 - $305,564

About The Position

The Study Physician, Immunology is an expert clinical-development role within our Rheumatology therapeutic area. Working as the study-level clinical authority within a program led by the Global Clinical Program Lead (GCPL), you will provide expert medical and scientific input across our rheumatology programs. You will begin in Rheumatology and may contribute to additional indications, modalities, and clinical development programs as the portfolio evolves. You will partner closely with the Clinical Scientists on the study team and collaborate cross-functionally at the enterprise level, including with Oncology, Alexion, and development partners. The successful candidate will thrive in a fast-paced, proactive culture and be a strong communicator and collaborator, both internally and externally. You will report to the Global Clinical Head, Rheumatology, or their designee, and work in close partnership with the Global Clinical Program Lead, who leads the program's clinical development strategy.

Requirements

8 years’ experience, an MD, or equivalent degree from an accredited university, or an MD (or equivalent) plus a PhD, with specialty or experience in the immunology or neuroimmunology therapeutic area. Cell-therapy experience is ideal.
Postgraduate subspecialty training and board certification in a relevant field such as neurology, with a history of substantive clinical positions at attending or consultant level, preferably at a major academic medical center.
Prior biotechnology or pharmaceutical clinical-development experience, including hands-on involvement in the design, delivery, interpretation, and oversight of industry-sponsored clinical studies. Experience working effectively within cross-functional drug development teams and operating with the level of autonomy expected of a study physician.
Sound understanding of the full drug-development process, clinical research methodology, and biostatistics principles, enabling efficient trial design and data-driven decisions.
Knowledge of FDA, EMA, MHRA, and ICH GCP guidelines for the conduct of global clinical studies.
Adaptive problem-solving and the ability to navigate complex organizations, influence internal and external stakeholders, and frame clear, succinct messages that simplify complex decisions.
Attention to detail, a drive for high-quality work, a sense of urgency, and a demonstrated track record of delivering results.

Nice To Haves

Experience in CAR-T or other engineered cell therapies, and/or T-cell engagers, in autoimmune or inflammatory indications.
Familiarity with cell-therapy operational constraints such as chain-of-identity/control and vein-to-vein logistics, and with CMC-clinical interfaces.
Experience in Sjogren’s Disease or myositis
Experience working effectively with cross-functional partners across clinical development and commercial organizations.
Awareness of the evolving external landscape in rheumatology, including scientific, clinical, competitive, and regulatory developments.
Ability to travel nationally and internationally.

Responsibilities

Provide expert medical and scientific input to cell-therapy and immunotherapy clinical-stage assets in development for Rheumatology and additional immune-mediated diseases.
Act as clinical authority representative for the study team. With senior support as needed, you will be responsible for the design, delivery, and interpretation of clinical studies from Phase 1 through pivotal, ensuring compliance with GCP.
Lead the medical assessment of causality, severity and benefit-risk for safety events, and provide medical sign-off on safety-related decisions such as dose holds and stopping-rule application. Own ongoing review and monitoring of clinical data for quality, data integrity, data-trend investigation, and safety, including SAEs, SUSARs, protocol deviations, and periodic review of emerging safety, efficacy, PK, and biomarker data both internally and via SRC/DMCs.
Represent the study at the Safety Review Committee, IDMC/DMC, and internal safety governance. Adjudicate complex clinical cases, including MS relapse adjudication, and sign off endpoint definitions and thresholds.
Support the clinical development strategy from early target identification through late phase, with senior support as necessary, and secure cross-functional alignment across the wider AZ organization.
Provide clinical and disease expertise to research, clinical pharmacology, translational medicine, regulatory, biostatistics, safety, the cell-therapy delivery team (including CMC), and commercial colleagues as part of a cross-functional team.
Follow medical developments in cell therapy and immune-mediated disease closely, and disseminate insight within Clinical Development and the wider organization to translate emerging data into innovative clinical plans.
Support the program at internal governance interactions and with external partners, as aligned with senior management. This includes investigators, key external experts, patient-advocacy groups, regulators, sites, and CROs.
Contribute medical content and final medical review to clinical sections of study- and program-level documents such as protocols, ICFs, IB, briefing books, BTD, PIPs, SAPs, and safety periodic reports, providing risk-benefit framing and clinical rationale.
Support qualification of pharmacodynamic and disease markers for early assessment of efficacy.
May provide clinical strategic feedback on in-licensing opportunities.