Associate Director / Principal Scientist I, Precision Medicine Immunology

AbbVie•Waltham, MA

7d•$141,500 - $268,500•Onsite

About The Position

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.

Requirements

Principal Scientist I: PhD, PharmD and/or MD with 4+ years, MS with 6+ years, or BS with 10+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of translational and precision medicine science required. Will hire at level according to experience.
Associate Director: PhD, PharmD and/or MD with 6+ years or MS with 8+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of translational and precision medicine science required. Will hire at level according to 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
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

Nice To Haves

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
Expertise in dermatology highly desirable
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics, protocol design, and/or experience in development strategy preferred.

Responsibilities

Lead or co-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.