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Role Summary
Translational Science Associate Director Immunology Cell Therapy
Responsibilities
Implement translational and biomarker objectives for cellular therapies for immune-mediated diseases.
Establish effective collaborations between research and development; differentiate AZ cellular therapeutics; drive translational understanding of clinical trial data.
Lead all aspects of translational studies and deliverables with CROs and collaborators to support new and ongoing clinical studies; enable LCM strategy and new program strategies as a GPT level translational lead.
Act as an authority in translational science, addressing difficult drug projects and complex scientific problems with innovative solutions.
Qualifications
PhD or MD-PhD required; degree or training in Immunology preferred.
5 years of industry experience with 3+ years in clinical development or translational science (industry or combined academic/industry).
Strong understanding of immune-mediated disease pathogenesis and application of cellular/molecular technologies to drive program decisions.
Experience in clinical biomarker development of T-cell therapy and/or other advanced modalities (in-house or with CROs).
Experience in BM, precision medicine, and IND filings.
Ability to learn new information rapidly; experience leading CROs for translational studies and biomarkers for clinical trials.
Experience authoring regulatory documents; understanding of full drug development process.
Strong biostatistics and translational/clinical research methodology knowledge; familiarity with FDA, EMA, MHRA and ICH GCP guidelines.
Experience beyond Phase 1 preferred.
Attention to detail, quality-focused work ethic, and urgency to achieve goals; proven track record delivering results.
Excellent verbal and written communication; strong analytical, problem-solving, and strategic planning skills.
Skills
Translational science leadership
Biomarker development
Clinical development strategy
Regulatory documentation
Collaboration with CROs and cross-functional teams
Biostatistics and data interpretation
Education
PhD or MD-PhD; Immunology training preferred.
Additional Requirements
In-person/office-based collaboration pattern; emphasis on leadership and stakeholder engagement.