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Senior Director/Executive Director, Developmental DMPK Leader

This position is based in Shanghai, China, reporting to Head of DMPK Services at WuXi AppTec.

Job responsibilities include but not limited to:

  • Serve as a leader of developmental DMPK projects.  Accountabilities include building and optimizing IND-enabling capabilities at WuXi DMPK, interacting with clients in designing IND-enabling packages toward filings to FDA and CFDA, interpreting IND data package and suggest follow-up studies targeting successful IND submissions, training DMPK project managers, collaborating with other developmental functions at WuXi AppTec, such as Tox, CMC, pharmacology and formulation departments.
  • Lead the developmental DMPK project management team. Serve as a mentor and educator to subordinates as well as promote full career development potential.
  • Work closely with business development staff to explore new clients to achieve revenue target
  • Work with functional groups to improve operational productivity
  • Manage multiple client accounts to achieve client satisfaction and eventually revenue growth
  • Identify and establish appropriate new technologies relevant to ADME and PK characterization in preclinical and clinical development.
  • Involvement in departmental strategic planning.

Qualifications

  • PhD in pharmacokinetics and drug metabolism along with 10 or more years of relevant industrial experience.
  • Strong capability and track record of DMPK representation in support of drug development projects.
  • Broad familiarity with drug development process and regulatory guidelines.  Deep knowledge and hands-on experience in preparing filing documentations (IB, CTD, etc.) and preferably experience in interacting with regulatory agencies.
  • Problem solving (scientific and managerial) skills and ability to promote an open-team oriented environment
  • An outstanding record of publications in PK/ADME-related journals.