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Position:
Job Title: Senior Director, Toxicology    

Employer:
Simcere of America Inc.

Description:

The candidate will be responsible for oversight of the nonclinical safety program and provide scientific leadership and expertise by contributing to the safety assessment of therapeutic protein. The candidate should possess an extensive knowledge of the regulatory requirement on IND enabling nonclinical studies, and have experience formulating the nonclinical safety strategies, designing toxicology studies, authoring regulatory documents. Previous experience in evaluating drug candidates for potential in-licensing and addressing nonclinical safety issues is preferred.

This position will be a key member of the R&D team supporting multiple areas including toxicology, bioanalytical sciences, PKPD and clinical pharmacology. S/he may also be as a primary representative on program teams and in collaboration and interaction with other functions in across development programs.

  • Develop and implement nonclinical safety strategies, design toxicology studies, author regulatory documents.

  • As a member of an integrated project team, interact with internal and external partners, and as well as regulatory agencies.

  • Ensure high scientific standards in conducting and reporting of nonclinical safety and investigative toxicology studies, and working with research project teams to utilize and interpret animal models of diseases for efficacy assessment and PK/PD evaluation

  • Manage studies at CROs and monitor to ensure high-quality deliverables of the safety studies.

  • Work with the senior management to manage the departmental budget and resource.

 



Qualifications/Experience:

  • PhD in biology, toxicology or related field and/or DVM, MD

  • Board certification in toxicology and / or pathology is highly desirable

  • 10+ years in preclinical safety assessment of novel therapeutic entities

  • Knowledge and experience on GLP compliance and relevant ICH & FDA guidance documents

  • Experience in interfacing a preclinical function with QA, bioanalytical sciences, regulatory affairs,

    CMC, and clinical development functions

  • Excellent interpersonal skills and communication skills

  • Results oriented with strong problem-solving skill

 



Location: Nanjing or Shanghai, China

Contact: Chen Chen (chen.chen@simcereusa.com)

Post Date: 11/6/2018 2:15:42 PM
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