DRUG METABOLISM-PHARMACOKINETICS (DMPK) Mission Statement:
This position will be responsible for the development and oversight of the DMPK function in a manner that conforms to established industry standards and relevant regulatory guidelines. The position will report to the Director of Preclinical Safety Evaluation. Responsibilities:
• Design, interpret, and report pharmacokinetic studies and toxicokinetic components of toxicology studies in support of preclinical and clinical development
• Guide clinical team members in selection of dose, dose formulation, route of administration and dose frequency in Phase I clinical study design
• Actively participate in interdisciplinary project teams dedicated to planning and execution of INDs and other regulatory submissions
• Peer review reports and regulatory submissions for GLP compliance, completeness and scientific merit
• Interact with Quality Assurance to schedule and resolve audits
• Create and modify standard operating procedures as needed
• Create and modify laboratory methods as needed
• Develop organizational growth and outsourcing strategies for DMPK function Qualifications:
• Ph.D. in a related discipline with 5+ years of industry experience.
• Extensive knowledge of pharmacokinetic and pharmacodynamic principles
• Experience in the development of biotherapeutics with an overall understanding of drug research and development
• A thorough knowledge of preclinical and clinical pharmacology
• Project team / Project Management experience representing the preclinical DMPK function
• Working familiarity with Good Laboratory Practice (GLP) Regulations
• Experience in preparation of regulatory submissions and interaction with regulatory authorities on preclinical and clinical DMPK issues
• An overall understanding of biotherapeutic method validation, bioanalytical sample analysis, and various instrumentations (HPLC, LC/MS/MS, GC, ELISA, Biacore, etc.)
• Experience with analytical software such as WinNonlin, NONMEM, or similar programs |
