Job Description

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.

• 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.

• 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.

• 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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