AbbVie DMPK Discovery Project Representative in Worcester, Massachusetts
The Drug Metabolism and Pharmacokinetics (DMPK-BA) group is searching for a DMPK-BA representative in Worcester, MA to provide project support in Immunology Discovery, enabling biologics (mAb, ADCs, DVDs) progression from discovery to early stages of clinical development. The scientist will provide recommendations for key PK and biomarker studies based on project needs and follow up on the executed strategy plan as integrated member of the project teams. In addition, the successful candidate will also support in PKPD modeling.
Key Responsibilities: * Represent DMPK-BA in project teams, and provide project support to enable biologics progression from discovery to early stages of clinical development * 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 design, human dose prediction, and calculation of therapeutic index * Coordinate and request PK, PKPD, bio-analytical (BA), safety studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times * Ensure that PK, PKPD, BA and PKPD data/methods are provided to and understood by project team * Prepare DMPK-BA section of IB, IND and response to regulatory questions and ensure generation of appropriate reports * Liaise with Immunology discovery biology/pharmacology and clinical pharmacology to help in the development of PKPD models that will generate data and knowledge to build translational PKPD strategy, including Biomarker Strategy * Ability to clearly communicate internally and externally on topics related to PK and PKPD * Keep up to date with emerging literature and science related to the job
Level and compensation will be commensurate with experience.
Basic: * Bachelors, Masters, or Doctorate (Ph.D.) in PKPD modeling, Biological Sciences, Pharmacology, Pharmacometrics, Pharmaceutical sciences or related field, with at least 10 (BS), 8 (MS), or 0 (Ph.D) years of pharmaceutical industry experience supporting Biologics projects. * Must have a strong understanding of PK and human dose prediction for biologics, and be able to give clear recommendations for the design of preclinical and clinical PK studies. * Experience with biologics is required. * Ability to influence, negotiate and communicate with both internal and external stake holders. * Hands-on experience in modeling software such as Phoenix, WinNonlin. * 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, persons 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. Preferred: * Ph.D in PKPD modeling, Biological Sciences, Pharmacology, Pharmacometrics, Pharmaceutical sciences or related field 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-Massachusetts-Worcester
Organization: Research & Development
Travel: Yes, 10 % of the Time
Req ID: 1606465
Equal Opportunity Employer Minorities/Women/Veterans/Disabled