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.
- 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.