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Study Director, DMPK

Responsibilities:

  • Capable of representing the entire DMPK function to support drug discovery and/or development programs. Clearly understand the scope and milestones of the programs. Identify DMPK challenges and propose roadmap and solutions as appropriate.
  • Communicate proactively with clients and propose/agree on DMPK studies to address key program issues or potential risks. Collaborate with functional groups to conduct study design and submit study requests timely.
  • Work closely with internal functional groups to monitor the progress of submitted studies and ensure timely execution. Propose alternative plans when an accident or unexpected event occurs.
  •  Analyze and integrate all data (in vitro ADME, in vivo PK, BA and met ID) to assess if conducted studies have addressed or clarified the scientific questions asked, or have tested the hypothesis proposed earlier. 
  • Ensure timely delivery of study reports to the clients with high quality and an appropriate scientific summary. Formulate hypotheses and scientific rationale to account for the study results and propose further studies to confirm it as appropriate.
  • Be able to consolidate DMPK data and present in DMPK program review. Invite advices and advocate scientific discussions as needed.
  • Work with all functional groups to offer technical support to the study design, quotation, and conduct; move studies forward with sense of urgency: thinking on behalf of client.
  • Put high value on technical input from technical staff that perform the actual study.
  • Exhibit superior verbal and written communication skills and exhibit superior interpersonal and leadership skills as necessary to ensure study activities conducted by multiple groups are executed smoothly and according to the protocol.
  • Effectively manage multiple studies and review and deliver final report in a timely manner to serve the client.
  • Be able to work independently on assigned studies under minimal supervision.
  • Provide support for both drug discovery and development DMPKs; lead or coordinate cross BU integrated programs


Basic Qualifications:

  • Ph.D. or equivalent degree with 5-10 years' industry experience in the field of drug metabolism and pharmacokinetics or equivalent life-science based discipline.
  • In depth knowledge of DMPK with extensive hands-on experience on common ADME assays, PK analysis, simulation and modeling. Capable to identify and solve DMPK issues under minimum guidance.
  • Familiar with early discovery strategies and/or late stage development process. Experience with Medchem programs and FDA/CFDA IND filing is a plus.
  • Able to work independently and communicate effectively with a multidisciplinary team of medicinal chemists, biologists, pharmacologists and toxicologists.
  • Excellent written and verbal communication skills in both English and Mandarin Chinese.


Job Function: Research & Development

Primary Location: China-Shanghai