AbbVie Oncology DMPK Project Representative in Lake County, Illinois

Description:
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 28,000 people worldwide and markets medicines in more than 170 countries.

Description

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology organization focusing on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots combine their expertise in immuno-oncology, stem cells, apoptosis and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments.

The Translational Modeling & Simulation department within the Drug Metabolism and Pharmacokinetics (DMPK) group is searching for a DMPK project representative in LC, to provide project support enabling biologics progression (incl. antibody-drug conjugates (ADCs) and bi-specifics) in Oncology discovery and clinical development. The scientist will provide recommendations for key in vitro ADME, in vivo pharmacokinetics, and biomarker studies based on project needs and follow-up on the executed strategy plan as an integrated member of project teams.



Key Responsibilities: * Serve as a DMPK-BA representative on project teams supporting the development of novel biologics (including ADCs and bispecifics) for the treatment of various diseases primarily in the Oncology Therapeutic area * Collaborate with cross-departmental project team members and other groups within DMPK-BA to enable knowledge and data integration guiding target validation, biomarker selection, candidate selection, (pre)clinical study designs, human dose predictions, DDI modeling and calculation of therapeutic index * Show thorough understanding of the selection and characterization of antibodies, bispecifics, and antibody drug conjugates * Coordinate and request PK, PKPD, an bio-analytical (BA) studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times * Liaise with Oncology Discovery Biology/Pharmacology and Clinical Pharmacology to help in the development of PKPD models that will generate data and knowledge to build translational PKPD and Biomarker strategy * Serve as a liaison with the small and large molecule bioanalytical groups to ensure reagent generation, method development and sample analysis timelines are met * Prepare DMPK-BA sections of IB and IND; provide response to regulatory questions and ensure generation of appropriate reports

Qualifications:
Level and compensation will be commensurate with experience.



Basic: * Bachelors, Masters, or Doctorate (Ph.D.) in Pharmaceutical Sciences or related field and at least 3 years of relevant experience in the pharmaceutical industry * Experience in representing DMPK on biologics project teams is required (expertise in ADC development is a plus) * Expertise with PK analysis of biologics is required * Experience with Phoenix/WinNonlin modeling software is desired * Understanding of biologics PK/PD modeling and ligand binding assays for measuring biologic molecules and/or biomarkers in preclinical study samples is desired * Ability to influence, negotiate and communicate with both internal and external stake holders. Ability to work well in a collaborative fast-paced team environment. * Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills, capable to work both as team player and project driver. * High degree of flexibility in adapting to different projects, people and excellent networking and relationship-building (both internal and external) skills are required. * Passion for data analysis, solving technical problems and applying new technologies to further scientific goals



Key Leadership Competencies: * Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance * Learns fast, grasps the "essence" and can change course quickly where indicated * Raises the bar and is never satisfied with the status quo * Creates a learning environment, open to suggestions and experimentation for improvement * Embraces the ideas of others, nurtures innovation and manages innovation to reality

Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 10 % of the Time
Req ID: 1703479

Equal Opportunity Employer Minorities/Women/Veterans/Disabled