- Charles River Laboratories (Mattawan, MI)
- …large molecules and their immune responses. The main types of assays include Pharmacokinetic ( PK ) assays to measure drug and Immunogenicity assay to measure ... anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Other assay types also performed are branched DNA (bDNA) and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery (MSD),… more
- Allucent (Cary, NC)
- …blogs, clinical protocols, clinical study reports, clinical pharmacology strategic plans, pharmacokinetic analysis plans (PKAPs), PK reports, modeling analysis ... plans (MAPs), modeling reports, INDs, clinical pharmacology sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents + Collaborate on internal initiatives such as developing templates and guidelines to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure timely and accurate execution of clinical pharmacology studies. + Conducts PK -PD and related analyses and provides clinical pharmacology input into or ... technical information clearly to others are required. + Experience using pharmacokinetic program and analysis software (such as WinNonlin) + Experience leading… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …modeling techniques using SAS JMP. The summer project may involve reviewing pharmacokinetic ( PK ) and pharmacodynamic (PD) data from clinical trials. Students ... will be trained on techniques for data cleaning, statistical analysis, and linear regression (univariate and multivariate). The student will work closely with the global program head, medical director and clinical pharmacology director during the project.… more
- Lilly (Boston, MA)
- …of the Lilly portfolio + Design and implement hypothesis driven studies to answer ADME, PK /PD and clinical pharmacology questions + Integrate ADME, PK and PK ... clearly + Experience in drug discovery and development + Experience with PK /PD modeling and/or bio-distribution + Ability to balance multiple projects and handle… more
- AbbVie (North Chicago, IL)
- …models that achieve projects, Clinical Pharmacology and Pharmacometrics goals. Propose PK /PD modeling and simulation ideas and implement those efforts. Investigate, ... identify, develop, and optimize methods and techniques in the field of PK /PD modeling. Act as a lead pharmacometrician in his/her area of expertise and critically… more
- J&J Family of Companies (Spring House, PA)
- …gain hands-on experience in CPP principles, including pharmacokinetics/pharmacodynamics ( PK /PD), translational modeling, and model-informed drug development (MIDD) ... such as: + Clinical Pharmacology and Medical literature review + Data analysis of PK , biomarker, preclinical and/or clinical data, trial design, etc. + PK and… more
- Taiho Oncology (Pleasanton, CA)
- …assess external acquisitions. + Conduct or oversee data analysis and reporting of PK data generated by TOI-sponsored clinical trials and writing or reviewing the ... documents: + + Clinical Study Reports. + Investigator Brochures. + Population PK and/or Exposure-Response reports. + Regulatory Documents, including NDAs and MAAs… more
- Amgen (Thousand Oaks, CA)
- …in vivo, for characterizing ADME and elucidating pharmacokinetics and pharmacokinetic -pharmacodynamic relationships. In addition to leading teams within PKDM-BA, you ... and interpret results from in vivo studies characterizing pharmacokinetics, pharmacokinetic -pharmacodynamic relationships, tissue distribution, and toxicokinetics of antibody-siRNA conjugates… more
- University of Michigan (Ann Arbor, MI)
- …of this position from a departmental perspective include code blue response, pharmacokinetic monitoring and dosing for specific drugs, order review and verification, ... orders, provide dosage adjustments per pharmacy policies for anticoagulation, pharmacokinetic antimicrobials, renally dosed medications, parenteral nutrition, and conduct… more