Purpose Statement (2-3 Sentences):
Describe the primary goals, objectives or functions or outputs of this position:
The Precision Medicine Immunology group is hiring an experienced translational scientist with expertise in immunology who will be responsible for the development, planning, execution, and interpretation of translational medicine activities in support of the immunology clinical development portfolio at AbbVie.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
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.
List required and preferred qualifications (up to 10). Include education, skills, and experience.
- 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 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
- Expertise in dermatology, rheumatology, and/or gastroenterology 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
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced