Index Ventures

Position Purpose

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

Key Skills and Attributes:

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

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