Job Description

Key Responsibilities

1. DMPK Strategic Planning
   Develop the overall DMPK (Drug Metabolism and Pharmacokinetics) research strategy and plan in alignment with the company’s R&D pipeline strategic objectives, covering the entire process from early discovery, lead compound optimization, candidate molecule selection to preclinical development.
2. Small and Large Molecule DMPK Research
   Lead preclinical in vitro ADME and in vivo pharmacokinetics studies for both small molecule and large molecule drugs (including antibodies, ADCs, nucleic acids, polypeptides, etc.). Be responsible for experimental protocol design, data analysis and scientific interpretation, identify and assess PK/ADME-related risks, and support developability assessment and structural optimization.
3. IND Submission Support
   Responsible for drafting and reviewing DMPK-related IND/NDA submission dossiers (for both China NMPA and US FDA), support domestic and international registration submissions, and respond to pharmacokinetics-related inquiries from regulatory authorities.
4. CRO Management and Outsourced Studies
   Evaluate CRO qualifications, and take charge of end-to-end management of outsourced DMPK studies, including protocol communication, progress tracking, quality audit and research report review, to ensure research quality and compliance.
5. PK/PD Modeling and Human Prediction
   Conduct human PK prediction and dose estimation using approaches such as cross-species extrapolation and PBPK (Physiologically Based Pharmacokinetic) modeling; perform DDI (Drug-Drug Interaction) risk assessment based on experimental data and modeling tools; proficient in professional software including WinNonlin, Simcyp and GastroPlus.
6. Quality and Compliance
   Establish and maintain the DMPK research quality management system to ensure experimental data is compliant, accurate and traceable; participate in or support GLP study site inspections, audits and regulatory inspections.
7. Cross-Departmental Collaboration
   Serve as the key DMPK functional expert, work closely with antibody, medicinal chemistry, toxicology, CMC, clinical, regulatory affairs, BD (Business Development) and other teams to provide professional support for project decision-making; participate in DMPK assessment and due diligence for project in-licensing.
8. Team Building
   Build and lead the DMPK team, develop team members’ professional capabilities, and improve overall work efficiency and quality.

Job Qualifications

1. PhD degree in Pharmacokinetics, Pharmaceutics, Pharmacology, Drug Metabolism or related disciplines.

2. At least 8 years of DMPK-related innovative drug R&D experience in the pharmaceutical industry.
3. Combined DMPK research experience in both small molecule and large molecule drugs, familiar with the differences and research methodologies between the two in terms of ADME, bioanalysis, immunogenicity and other aspects.
4. Familiar with NMPA/FDA/ICH guidelines on DMPK for small molecules and biological products, with successful IND submission experience.
5. Excellent oral and written English communication skills, ability to independently prepare English submission dossiers, and support international project communication and engagement with global regulatory authorities.
6. Proven CRO management experience, familiar with GLP standards and non-clinical study quality management requirements.
7. Proficient in PK/PD modeling and simulation software (e.g., WinNonlin, Simcyp, GastroPlus, etc.).
8. Excellent cross-departmental communication and coordination skills, team leadership and problem-solving capabilities.