AbbVie Scientific Director, Precision Medicine Immunology in Worcester, Massachusetts
The candidate will:
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.
PhD, PharmD and/or MD with 8+ years or MS with 10+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of Translational Sciences and relevant Therapeutic Area required. Will hire at level according to experience.
Strong scientific background in immunology or related field supported by publication record in these areas
Expertise in dermatology highly desirable
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
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, flow cytometry is a plus
Ability to manage clinical translational programs and teams with minimal supervision.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.
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