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Sr Principal Scientist

Req #: 1700599
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The Senior Principal Scientist is responsible for developing and executing modeling based strategies for preclinical projects, leading development of PBPK/PK-PD models for human dose projections and drug-drug interaction evaluation, representing DMPK on cross-functional project teams.  He/she will collaborate with Clinical Pharmacology, Toxicology, Chemistry, and Formulation groups to address drug development issues associated with drug candidates.

Responsibilities will also include, but are not limited to, the following:

Lead PBPK and PK/PD modeling and simulation work within DMPK using various software platforms including SimCYP, GastroPlus, Phoenix/WinNonlin and MatLab/Simbiology. Represent DMPK on cross-functional project teams, including preparing project strategies and development plans. Oversee internal and outsourced DMPK activities, including study design, protocol and report preparation, and data interpretation. Apply novel modeling techniques and approaches to address DMPK issues. Become an internal resource for modeling activities and work closely and mentor other scientists. Represent Celgene at external settings (eg; consortia) as preclinical modeling and simulation leader. Collaborate with discovery DMPK colleagues to develop PK-PD relationships to guide lead optimization and candidate selection. Prepare and critically review submission documents such as CTD sections for INDs, Investigator Brochures, briefing books. Keep management apprised of project status and current scientific trends using written and oral summaries, as well as presentations. Participate in preparing Nonclinical Development Work Practices and SOPs.

Skills/Knowledge Required:

  • In depth understanding of PBPK modeling software such as SimCYP and GastrPlus are a necessity.
  • Broad based understanding of in vitro and in vivo techniques used to characterize drug metabolism, pharmacokinetics and drug interactions potential of drug candidates.
  • Effective at working with interdisciplinary project teams, including helping to develop DMPK strategies and implement drug development plans.
  • Ability to oversee studies performed internally or at external contract research laboratories.
  • Awareness of regulatory requirements in the areas of drug metabolism, drug-drug interactions, bioanalysis, toxicology, and clinical pharmacology.
  • Experience preparing drug metabolism reports and regulatory submission documents.
  • Strong written and verbal communication skills, and computer proficiency are required.

Ability to multi-task and work in a collaborative team environment.

  • Degree:  Ph.D. and 12+ years preferred post Ph.D. in biochemistry, pharmaceutical sciences, biology or related fields with extensive industry experience and track record of solid contributions in preclinical and clinical biologics drug development/pharmacokinetics/immunogenicity.
  • Years of Experience: - 10+ years of corporate pharmaceutical industry experience preferred.

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Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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