Position Responsibilities/Major Duties:
? Provide clinical pharmacology expertise in clinical drug development from IND to NDA/ or BLA
? Develop PK/PD prediction models from in vitro and non-clinical data to support FIH dose selection
? Implement model-informed drug development using quantitative approaches to address drug development questions
? Oversees and manages commercial development of the product PK profile and ADME profile characterization in accordance with regulatory requirements for Phase I-III and NDA/BLA.
? Development of a priori in vivo non-compartmental and compartmental PK models and identification of independent covariates impacting the justification of dosing and optimizing potential safety and efficacy.
? Provides critical input into PK data collection, analyses and quality control in accordance with regulatory requirements, including and not limited to implementing practical intensive PK sampling and analysis, population-based PK and feasibility/risk management.
? Proactively addresses GAP requirements for pharmacology summaries and sections of IND, EOP2, and NDA/BLA submissions.
? Ensure appropriate PK-PD analysis including population PK, Exposure-response analysis, modeling and simulation, and meta-analysis, etc.
? Author relevant sections of regulatory documents including clinical protocols, clinical study reports, population PK reports, exposure-response analyses reports, investigator brochure and others
? Conduct data analyses and generate reports for pre-clinical PK/TK data and clinical data using non-compartmental analyses, modeling and simulation as well as literature data analysis
? Participate and present at company meetings, and lead discussions of clinical pharmacology
? Communicate with regulatory authorities to address questions of clinical pharmacology
? Author scientific publications and present at scientific conferences
Education and Experience:
? PharmD or PhD, DVM or MD degree
? At least 5 years of experience in developing and validating non-compartmental and compartmental PK/PD models for oncology drugs, starting dose justification for FIH studies, use of MABEL methods and principles as well as conventional scientific regulatory principles for starting dose justification and escalation.
? Experienced in Model-based Phase I dose escalation and dose justification methods (will need to provide examples)
? Capable of performing proper PK meta-analyses on populations and cross comparisons of potential bioequivalents.
? At least 2-3 years of experience in clinical pharmacology with in-depth knowledge and understanding of IND, NDA/BLA pharmacology regulatory requirements
? Working knowledge of PK program and analysis software (WinNonlin, PHOENIX, SAS etc) along with PK modeling and computer skills in scientific graphing and presentation
? Excellent oral and written communication skills
? Oncology experience required
? Fluency in Chinese a plus
? Well in English oral expression and PPT presentation