Jobs
View more job listings or post a job
PTC Therapeutics Scientist I - Translational Omics
Applied BioMath Quantitative Systems Pharmacology Modeler - Project Lead/Group Lead
Sorrento Therapetuics Scientist/Sr. Scientist -- protein/gene characterization, LC-MS
Applied BioMath Senior Scientist - Pharmacometrics
Applied BioMath Senior Scientist - Mathematical Modeler
Evotec Senior Scientist
UC Davis - California Animal Health and Food Safety Laboratory TOXICOLOGY SECTION: LAB RESEARCH SUPERVISOR 2/GROUP LEADER (LAB RSCH SUPV 2)
Catalent Pharma Solutions Scientist - Molecular Biology / Protein Expression
Catalent Pharma Solutions Associate Scientist - Molecular Biology / Protein Expression
Protagonist Therapeutics CLINICAL PHARMACOLOGIST
Post a job


Position:
CLINICAL PHARMACOLOGIST

Employer:
Protagonist Therapeutics

Description:

The Clinical Pharmacologist will

  • Define and execute clinical pharmacology components of drug development programs, including planning, designing and oversight of studies
  • Plan and execute clinical pharmacokinetic and pharmacodynamic analyses to support portfolio projects
  • Apply quantitative approaches to develop and implement translational PK/PD strategies, inform dose and dosing regimen selection and support product development decisions.
  • Participate on and provide input to project teams
  • Contribute to regulatory documents (INDs, clinical trial documents including protocols and study reports, IBs, NDAs)


Qualifications/Experience:
  • PhD (or equivalent), Medical degree, or PharmD
  • >3 years experience in pharmaceutical drug development.
  • Background in pharmaceutical sciences, pharmacometrics, mathematics, (bio)statistics, biomedical engineering, or a related field.
  • Proficiency in R, NONMEM, Phoenix WinNonlin, NLME, Matlab, SAS, or other similar applications
  • Experience in performing population PK and PK/PD analyses using pharmacometric software
  • Good working knowledge of the drug discovery and development process.
  • Scientific understanding of biopharmaceutics, ADME, and clinical pharmacology
  • Demonstrated success in executing clinical pharmacology programs and quantitative drug development (population and mechanistic PK/PD modeling and simulations)
  • Experience with successful regulatory filings (IND, NDA/BLA, MAA)
  • Scientific excellence as demonstrated through track record of publications or presentations in clinical pharmacology and application of quantitative methods in drug development
  • Experience in experimental study design, problem solving, critical data analysis and interpretation
  • Good written and verbal communication, interdisciplinary collaboration and problem solving skills and ability to work in a fast paced environment


Location: Newark, CA

Contact: n.modi@ptgx-inc.com

Post Date: 4/6/2021 12:00:00 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 5/10/2021; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Alturas Analytics, Inc. Expert GLP & non-GLP LC-MS/MS, GC-MS/MS bioanalytical & PK/TK analysis services of small & large molecules in any matrix. Discovery through phase IV.
Hypha Discovery Synthesis, purification & NMR characterization of drug metabolites at mg-g scale with COAs, including CYP/AOX/FMO metabolites, glucuronides & sulfates
Eurofins Selcia 14C Custom Radiolabelling for pre-clinical studies (ADME, drug metabolism, QWBA) and GMP 14C-API for hAME, clinical mass balance /micro-dosing.
Submit a Text Ad