Position Responsibilities/Major Duties:
1. Provide clinical pharmacology expertise in clinical drug development from IND to NDA/ or BLA
2. Develop PK/PD prediction models from in vitro and non-clinical data to support FIH dose selection
3. Implement model-informed drug development using quantitative approaches to address drug development questions
4.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.
5.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.
6. 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.
7. Proactively addresses GAP requirements for pharmacology summaries and sections of IND, EOP2, and NDA/BLA submissions.
8. Ensure appropriate PK-PD analysis including population PK, Exposure-response analysis, modeling and simulation, and meta-analysis, etc.
9. Author relevant sections of regulatory documents including clinical protocols, clinical study reports, population PK reports, exposure-response analyses reports, investigator brochure and others
10.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
11.Participate and present at company meetings, and lead discussions of clinical pharmacology
12. Communicate with regulatory authorities to address questions of clinical pharmacology
13.Author scientific publications and present at scientific conferences
Education and Experience:
1.PharmD or PhD, DVM or MD degree
2.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.
3.Experienced in Model-based Phase I dose escalation and dose justification methods (will need to provide examples)
4.Capable of performing proper PK meta-analyses on populations and cross comparisons of potential bioequivalents.
5. At least 2-3 years of experience in clinical pharmacology with in-depth knowledge and understanding of IND, NDA/BLA pharmacology regulatory requirements
6.Working knowledge of PK program and analysis software (WinNonlin, PHOENIX, SAS etc) along with PK modeling and computer skills in scientific graphing and presentation
7.Excellent oral and written communication skills
8.Oncology experience required
9.Fluency in Chinese a plus
10. Well in English oral expression and PPT presentation