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Principal Scientist, Clinical Pharmacology and Pharmacokinetics

Req #: 17001328
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 10 % of the Time
Other Locations:US- NJ- Summit West

Responsibilities include:

  • Serve as the department lead person for clinical pharmacokinetics (PK) in studies and project teams.
  • Perform and accountable for non-compartmental PK data analysis
  • Plan, implement, interpret and report model-based PK and pharmacodynamics (PD) analysis including population PK, PK/PD modeling and simulation, meta-analysis for assigned compounds under clinical development from Phase 1 to 3 and in life cycle management.
  • Assist in selection of doses and dosing algorithms for clinical development.
  • Contribute to regulatory documents and meetings; take a lead role in writing and reviewing response to regulatory queries on clinical pharmacology/PK.
  • Provide input to clinical study designs and PK logistics.
  • Assist in the development of the statistical analysis plan.
  • Scientific oversight of CROs with respect to PK and PK/PD tasks.

Other Attributes:

  • Able to anticipate problems at project level.
  • Proven track record of scientific approach to complex problem solving.
  • Demonstrate in-depth, scientific-directed, innovative thinking.
  • Work with multiple studies/programs with moderate to limited oversight
  • Sets own priorities with some guidance
  • Keeps manager and key stakeholders informed on programs to assure alignment
  • Through knowledge of the global drug development process and key deliverable by multiple in collaboration from discovery to commercialization
  • Through and in depth knowledge of PK/PD and its application and impact on drug development
  • Thorough understanding of ADME principles in drug development
  • Good document authoring and review/edit skills
  • Recognize risk and propose contingency plans.
  • Acts as a resource to peers, multi-disciplinary teams, and senior management.
  • Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams.
  • Communicates within the larger organization and external community.

Qualifications:

  • Strong quantitative skills with hands-on experience in advanced data analyses, i.e. population PK, PK/PD, and exposure-response analyses.
  • Competent in the use of various modeling software (NONMEM, SAS, Splus, R, etc.) and standard noncompartmental data analysis software (Phoenix/WiNonlin).
  • Excellent written and verbal communication skills and demonstrated oral presentation skills.
  • Ability to work in a cross-functional team environment and to work simultaneously on multiple projects.
  • Knowledge and experience on clinical database, PK/PD data compilation and manipulation with scripting software of SAS, R and/or Splus.
  • Familiarity with all stages of drug development from discovery through Phase 4, including experience in the preparation of clinical pharmacology sections of regulatory submissions for IND- and/or NDA-stage projects.

Requirements & Education:

  • Advanced degree (Pharm.D. or Ph.D.) or equivalent degree in scientific discipline with a minimum of 6 years’ experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
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