Sr Principal Scientist (DMPK)

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical  companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven  track record of  success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.  Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.  As of January 2022, the Company has a global team of approximately 2000 employees.

Job Description

The Sr. Principal Scientist of DMPK oversees the quality and performance of DMPK and ADME activities including interactions with CROs and internal project stakeholders. This individual is responsible for leading DMPK interactions among our interdisciplinary drug discovery and clinical teams to facilitate drug development from lead compound optimization to preclinical and clinical development.

• Serve as the DMPK representative to ensure effective application and integration of ADME, PK, and PK/PD studies in support of discovery and development programs.
• Collaborate with other functions such as biology, pharmacology, toxicology, and translational medicine to define PK/PD relationship.
• Identify critical ADME/PK needs and propose strategies.
• Design and oversee DMPK studies, review and summarize results, integrate ADME, PK, PK/PD, and TK information to guide multi-disciplinary team efforts in lead optimization and to facilitate selection of development candidates.
• Design DMPK study, review study protocol, study results, and finalize reports.
• Draft and review DMPK and relevant sections of regulatory documents.
• Manage interactions with external CROs to ensure high quality and on-time execution of DMPK studies.

Qualifications

REQUIRED:

• Ph.D. degree with six years experience in small and large molecule drug discoveries and preclinical development.  Experience as DMPK lead on programs progressing to candidate selection, IND, CTA, or beyond is required.

PREFERRED:

• Experience operationalizing IND-enabling studies
• Demonstrated track-record and expertise in DMPK, ADME, PK/PD, as well as biotransformation and metabolite identification and characterization studies.
• In-depth understanding and strategic application of most in vitro and in vivo ADME assays, methods, and models. Ability to gather most relevant information to facilitate human PK and dose projection.
• Direct hands-on experience and strong trouble shooting skills in most in vitro and vivo DMPK studies, including PK and PK/PD analysis, quantitative and qualitative LC-MS analysis, in vitro and in vivo biotransformation, and drug interaction predictions.
• Expertise and experience in PK/PD analysis using Phoenix and other data analysis software, design, interpretation, simulation, and reporting to provide guidance for drug discovery and preclinical development projects.
• Expertise in managing CROs and knowledge of regulatory guidelines on DDIs, bioanalysis, and GLP practice.
• Experience in writing DMPK documents for CTA submission.
• Written and verbal fluency in Mandarin Chinese and English.

Additional Information

The pay range for this position at commencement of employment is expected to be between $180K and $200K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, a