Senior Scientist, DMPK
Senior Scientist, DMPK
A leading global biopharma is seeking an accomplished DMPK scientist to lead pharmacokinetic and bioanalytical activities for their growing portfolio of antibodies, ADCs, and other large-molecule therapeutics. Reporting to the Executive Director, DMPK, you will design and interpret PK/ADA studies, oversee external bioanalytical partners in the US and China, and ensure high-quality, compliant data packages that enable IND submission and early-phase clinical development.
Key responsibilities
PK strategy & study design
Develop and execute non-clinical and clinical PK, PK/PD, and immunogenicity plans for large-molecule programs.
Define sampling schemes, assay requirements, and data analysis approaches in consultation with cross-functional teams.
Bioanalytical method leadership
Lead development, validation, and troubleshooting of ligand-binding (ELISA/LBA) and hybrid LC-MS assays in accordance with GLP/GCLP guidelines.
Author and review validation protocols, SOPs, and bioanalytical reports for regulatory filings.
CRO management & material logistics
Select, contract, and manage CROs; monitor timelines, budgets, and data quality.
Coordinate shipment of drug substance, plasma/serum, and reference standards between US sites and China-based partners, maintaining chain-of-custody and import/export compliance.
Data analysis & reporting
Perform and/or direct NCA and population PK analyses (Phoenix WinNonlin, NONMEM, or equivalent).
Compile CSRs, IND sections, and responses to regulatory queries (FDA, NMPA).
Cross-functional collaboration
Serve as the primary DMPK point of contact for Discovery Biology, CMC, Clinical Development, and Regulatory Affairs.
Present study designs and results to governance committees and senior leadership.
Required qualifications
Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, or related field - or - M.S. with ≥ 8 years relevant industry experience.
Proven track record designing and interpreting PK/ADA studies for antibodies, ADCs, fusion proteins, or other large molecules.
Hands-on expertise with ELISA/LBA and hybrid LC-MS bioanalytical method development and GLP/GCLP validation.
Demonstrated experience managing bioanalytical CROs and troubleshooting assay transfer issues.
Proficiency with PK analysis software (Phoenix WinNonlin, NONMEM, Monolix, or similar).
Fluency in written Chinese and English; ability to review and annotate technical/regulatory documents in both languages.
Preferred qualifications
Experience supporting IND submissions and answering agency questions for biologics.
Familiarity with population PK/PK-PD modeling and simulation.
Prior responsibility for international material transfers and regulatory logistics between the US and China.
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