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Principal Scientist Clinical Pharmacokinetics Modeling and Simulation

Employer
Celgene
Location
Summit, New Jersey, United States
Start date
Oct 7, 2019

View more

Discipline
Clinical, Science/R&D, Biotechnology
Required Education
Doctorate/PHD/MD
Position Type
Full time
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Job Details

Req #: 1900865
Location: Summit, New Jersey, United States
Job Category: Research and Early Development
Work Location: 556 Morris Avenue 07901
Organization: Pharmacokinetics
Employee Status: Full-time
Job Type: Regular

Key Responsibilities include:
  • Supervise and/or perform non-compartmental pharmacokinetic (PK) data analysis using WinNonlin and interpret PK data.
  • Develop in-depth understanding of core project issues
  • Plan, implement, interpret and report PK and PK/PD investigations in Phase I, II, III and IV studies
  • Apply, interpret, and report innovative modeling approaches through meta-analysis of population PK and exposure-response data towards dose optimization and commercial benchmarking.
  • Work with CROs to conduct meta-analysis and report PK/PD data to support internal development (go/no go) decisions and registration.
  • Evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity, and to late stage Phase 3 development
  • Help support PK and PK/PD strategies for compounds under drug development for global regulatory submission and represent as clinical pharmacology/modeling simulation lead in regulatory interactions
  • Prepare, with supervision, the eCTD dossiers of sections 2.5, 2.7.1 and 2.7.2 for NDA submission
  • Recommends solutions to project and study teams
  • Organizes and aids departmental training
  • Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/ performance)

Required Qualifications:
  • Ph.D. in a relevant scientific discipline which includes pharmacokinetics with at least 8 years of work experience, preferred. Master's degree with at least 14 years work experience will also be considered.
  • A minimum of 4 years of experience analyzing preclinical and clinical pharmacology studies.
  • Basic understanding of the global drug dev. process and collaborations among multiple functions from discovery to commercialization.
  • Basic knowledge of the drug development process, GLP and GCP.
  • Hands-on experience in using modeling software (e.g. NONMEM, MONOLIX, Gastroplus)
  • Knowledge and experience in PK/PD and pharmacometric applications in all phases of clinical dev. process, PK/PD data compilation and manipulation with scripting softwares such as SAS, R and/or Splus.
  • Knowledge of drug disposition and clinical pharmacology characterization of drugs
  • Advanced scientific writing skills to explain complexity with clarity
  • Up-to-date with emerging literature and new scientific development


Preferred Qualifications:
  • Evidence of external impact through presentations, manuscripts are strongly preferred.


About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Company

At Celgene Corporation, we’re committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. As a global leader in biotechnology and CAR T cell therapy, Celgene is a place where employees can make a real impact on the lives of patients with unmet medical needs in cancer and inflammatory diseases.

As we rapidly advance our next wave of innovative medicines, we announce the creation of a new global Clinical Development Organization to accelerate and optimize clinical development across our entire mid- to late-stage portfolio. Our commitments in this area will further establish the function as a center of excellence and enhance our strategic leadership in discovery, development and commercialization.

Recognized by Forbes in 2018 as a Top 10 World’s Best Employer and by Business Insider as the #3 Most Reputable Pharma Company in the World, Celgene offers a unique work environment where you can help build the business, while building your career in ways you may not have thought possible. We’re looking for innovative self-starters who want to improve the lives of patients worldwide. For more information, visit https://www.celgene.com/careers/.

Company info
Website
Phone
908-673-9000
Location
Corporate Headquarters
86 Morris Avenue
Summit
New Jersey
07901
US

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