Department: Research Technology
Job Title: Principal Scientist / Associate Director, DMPK, Ph.D.
Summary
Experienced Scientist to design and conduct discovery and development in vitro and in vivo metabolism studies, isolate/identify metabolites by LC/MS, conduct quantitative analysis of drugs and metabolites in biological matrices, and analysis and interpretation of non-clinical and clinical PK data. This position requires supervision of junior scientists and managing day to day operation of the laboratory
Duties and Responsibilities
· Conduct in vitro metabolism studies (including in vitro metabolic stability, P450 inhibition, reaction phenotyping, metabolite identification/isolation) for discovery and development drug candidates.
· Assay development and quantitative analyses of drug and metabolites in various biological matrices.
· PK data analysis and interpretation for animal PK studies
· Develop protocols for radiolabeled ADME studies to be performed in preclinical species at a CRO
· Develop methods and analyze biological samples from radiolabeled preclinical/clinical studies for mass balance, metabolite profiling and metabolite ID.
· Organize experimental data, interpret and present study results to management and project teams in a timely fashion.
· Write study reports
· Assist department personnel on bioanalytical method development, PK, PK/PD and metabolism issues
· Serve on selected project teams and/or sub teams
· Prepare all relevant PK sections of nonclinical regulatory documents (study summaries, CTD tables, Annual Reports, Investigator Brochures, and integrated summaries for regulatory submissions) and respond to issues
Requirements
· Ph.D. or equivalent in Bioanalytical sciences, Pharmacokinetics, Pharmaceutical Sciences, or related discipline 8-10 years or more of industry and/or related ADME/PK experience.
· Must have 3-5 years of experience in managing people and day to day laboratory operations.
· Experience working with Contract Research Organizations, on GLP bioanalytical methods development and bioanalytical study conduct
· Must have hands-on experience in bioanalytical sample analysis using HPLC, LC/MS/MS and metabolite isolation/identification
· Must have experience conducting in vitro and in vivo metabolism studies.
· Good knowledge of drug metabolism, pharmacokinetic and pharmacodynamic principles, PK analysis
· Must have hands on experience with WinNonLin and other PK modeling software
· Experience working with radiolabeled drugs preferred but not a requisite.
· Excellent written and oral communication skills.
· Proven record of writing regulatory reports/documents