◔ Full-Time
➣ Location: Zhangjiang, Shanghai
☉ Senior Level
Responsibilities
- Support DMPK on the managing scientific activities drug discovery and development, especially in the PK study design, data analysis and interpretation. The work scope may involve clinical development as well.
- Be a go-to person for PK study, data analysis using WinNonLin.
- Coordinate and track PK internal and external works.
- Define PK, PK/PD, biopharmaceutical requirements in pre-clinical development; plan appropriate strategies in accordance with the Health Authorities requirement.
- Proactively manage links with other functions to ensure that pre-clinical PK/PD information are used optimally; facilitate constructive collaboration within drug development teams and with other internal partners.
- Monitor timelines and objectives, ensure accuracy of project and activity progress, assure rapid and effective communication of high-quality data and results to project teams.
- Contribute to the preparation of submission documents to global regulatory agencies. Prepares responses to inquiries from regulatory agencies with minimal supervision.
- To perform modeling based on preclinical PK and PK/PD data to assess exposure–safety and exposure–efficacy relationships and inform subsequent study design.
- As PK expert to support BD, participate in technical discussions and review proposal/quote.
Requirements
Skills and Decision-Making:
- Evaluate preclinical DMPK package to support developmental projects.
- Appropriate design and implement DMPK studies, summarizing, analyzing and interpreting pharmacokinetic results in preparation for submission to regulatory agencies.
- Supporting new business development by assessment of new business opportunities.
- Ensure quality and compliance with applicable policies, standard operating procedures, and regulations.
- Respond to regulatory authorities on pharmacokinetic related questions and issues.
Qualifications:
- Master’s degree and above on medical, pharmacy, pharmacology, biochemistry or chemistry with a minimum of 6-8 years of industry experience is required.
- Proficiency with pharmacometric tools (e.g., WinNonlin, NLME, R). Knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process.
- Ability to work as part of a cross functional team in a highly dynamic, matrixed, projectteam environment. Strong oral and written communication skills.
- Strong organizational and project skills.
- Critical thinking and problem-solving skills.
- Excellent verbal and written communication skills and fluent English in oral and writing.
- Good at PC skills on Word, Excel, PowerPoint, Outlook, MS Project.
- Proficient in applying AI tools in daily works.
If you are interested in joining our team, please send your resume to our HR department at nona.hr@nonabio.com.
