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.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
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