Principal Scientist/Associate Director, Precision Medicine Immunology

Role Summary

The Precision Medicine Immunology group is hiring an experienced translational and biomarker scientist with expertise in immunology who will be responsible for the development, planning, execution, and interpretation of translational precision medicine activities in support of the immunology clinical development portfolio at AbbVie.

Responsibilities

• Lead the development and implementation of translational and biomarker strategic plans for one or more clinical programs. Responsibility may extend from early translational development activities to mature product life cycle strategies and back translational activities
• Manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with the development, regulatory, and commercial strategies
• Lead asset-specific translational projects/teams in a matrix environment.
• Work with internal Operations group to coordinate activities such as sample management, technical validation of assays both internally and at external CROs, review of SOWs, and data management
• In collaboration with appropriate stakeholders, ensure that clinical translational budgets, timelines, publication strategies, and regulatory compliance requirements are incorporated into program strategy
• Author and review all translational medicine aspects of clinical and regulatory documents including development plans, study protocols, clinical study reports, and regulatory submissions.
• Lead scientific collaborations and therapeutic area key opinion leader interactions in collaboration with partners from Medical Affairs, Commercial, or other functions.

Proactively consult primary scientific literature, keep current on state of art technologies and emerging concepts in immunology.

Qualifications

• Principal Research Scientist: BS or equivalent education and extensive, Typically, 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
• Associate Director: Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
• Strong scientific background in immunology or related field supported by publication record in these areas
• Demonstrated leadership in translational sciences (employing pharmacodynamic, predictive and exploratory biomarkers) and experience with development of assays including ligand binding assays, IHC/IF, gene expression profiling, or flow cytometry is a plus
• Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex data sets emerging from clinical trials
• Expertise in rheumatology highly desirable
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics, protocol design, and/or experience in development strategy preferred.
• Ability to manage clinical translational programs and teams with moderate supervision.
• Excellent written and oral communication skills, ability to present results in a clear and concise manner, strong organizational skills with attention to detail, and effective time management with an ability to adapt to changing priorities

Strong interpersonal and collaboration skills to work in a team-oriented, matrix environment, and the ability to work through conflicts