Job Description

Position Summary:

Our client is searching for a creative, resourceful scientist for an important role in the DMPK/Bioanalysis group. The candidate will serve as the DMPK representative on discovery and development project teams to ensure effective application and integration of ADME and PK studies in support of discovery and development programs.

Essential Function:

• Conduct bioanalytical method development and qualification/validation to support drug/metabolites and biomarker analysis.
• Perform biological sample analysis in a timely manner to meet project needs.
• Design and oversee DMPK studies (including in vitro metabolic stability, P450 inhibition and induction, in vivo pharmacokinetics / ADME studies in animal models, drug interaction studies).
• Review and summarize results, integrate ADME and PK information to guide multi-disciplinary team efforts in lead optimization and to facilitate selection of development candidates.
• Select, manage and monitor CROs.
• Author internal reports, protocols and nonclinical documents for Regulatory submissions.
• Maintain good laboratory practice, safety, and record keeping.

Education and Experience:

• PhD in Pharmacokinetics/Pharmaceutical Sciences, or related disciplines with 2+ years of relevant experience; or MS with 5+ years of relevant experience; or BS with 8+ years of relevant experience.
• Strong understanding of in vitro and in vivo ADME assays, methods, and models.
• Direct hands-on experience in quantitative LC-MS/MS analysis, PK analysis and in vitro and vivo DMPK studies.
• Experience in managing CROs and sound knowledge of regulatory guidelines on bioanalysis and GLP practice.
• Familiar with Phoenix WinNonlin.

Required Competencies:

• Strong analytical, organizational and communication skills.
• Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues.