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Associate Director / Principal Research Scientist II, Precision Medicine Immunology

AbbVie

Waltham, MAFull TimeSeniorH-1B sponsor company
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Location
Waltham, MA
Employment
Full Time
Work model
On-Site
Level
Senior
H-1B history
94 approvals (FY2023)
Posted

About this role

Associate Director / Principal Research Scientist II, Precision Medicine Immunology Full-time Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Precision Medicine Immunology group is seeking an experienced translational and biomarker scientist with expertise in immunology to lead the development, planning, execution, and interpretation of precision medicine activities supporting AbbVie’s immunology clinical development portfolio. Key responsibilities include: Translational and biomarker strategy: Lead the development and implementation of translational and biomarker strategies for one or more clinical programs, spanning early translational development, mature product life cycle planning, and back-translational research. Biomarker execution and interpretation: Oversee the design, conduct, interpretation, and reporting of biomarker activities and data in alignment with development, regulatory, and commercial strategies. Cross-functional leadership: Lead asset-specific translational projects and teams within a matrixed environment. Operational coordination: Partner with the internal Operations group to coordinate sample management, assay validation at internal laboratories and external CROs, statement-of-work reviews, and data management. Program planning and compliance: Collaborate with key stakeholders to incorporate translational budgets, timelines, publication strategies, and regulatory compliance requirements into program strategy. Clinical and regulatory documentation: Author and review the translational medicine components of development plans, study protocols, clinical study reports, regulatory submissions, and other clinical and regulatory documents. External scientific engagement: Lead scientific collaborations and interactions with therapeutic-area key opinion leaders in partnership with Medical Affairs, Commercial, and other functions. Scientific expertise: Maintain current knowledge of the primary scientific literature, state-of-the-art technologies, and emerging concepts in immunology. Qualifications Education and experience: PhD, PharmD, or MD with at least 6 years of relevant experience, or MS with at least 8 years of relevant experience, in the pharmaceutical industry or an equivalent setting. Substantial knowledge of translational and precision medicine science is required. The position level will be determined based on experience. Scientific expertise: Strong scientific background in immunology or a related field, supported by a relevant publication record. Translational leadership and assay development: Demonstrated leadership in translational science, including the use of pharmacodynamic, predictive, and exploratory biomarkers. Experience developing assays, such as ligand-binding assays, IHC/IF, gene expression profiling, or flow cytometry, is preferred. Data analysis and visualization: Familiarity with data management and visualization tools, with experience collaborating with computational biologists to analyze complex clinical trial data sets. Therapeutic-area expertise: Expertise in rheumatology is highly desirable. Clinical development knowledge: Knowledge of clinical trial methodology, protocol design, regulatory requirements governing clinical trials, companion diagnostics, and development strategy is preferred. Program and team management: Ability to manage clinical translational programs and cross-functional teams with moderate supervision. Communication and organization: Excellent written

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