Job Description
Key responsibilities:
- Serves as a recognized toxicology expert and provides scientific and technical leadership to address toxicology issues and support China development programs.
- Collaborate with HQ to prepare the toxicology part of responses to inquiries from regulatory agencies (Investigator's Brochure, non-clinical assessment sections of INDs, CTAs, and NDAs, etc.).
- Act as the project team representative for toxicology on multidisciplinary project teams.
- Be the interface with toxicology with HQ, health authorities, and the toxicology community to expand our company’s local presence and influence in the field.
- Highly organized individual to manage multiple projects, and work within cross-functional team.
Qualifications
Required:
- PhD in toxicology, pharmacology, or a related biological science with 5+ years of experience, or master's degree with 7 years of experience in the biotech/pharmaceutical industry.
- Understanding of current existing guidelines, regulations, requirements, and standards (GLP, ISO, OECD, ICH, etc).
- Proven ability to communicate well within a multifunctional drug development team, with excellent oral and written communication skills.
- The ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- The ability to proactively develop connections within the organization and with the external scientific community and utilize these resources in the resolution of issues.
Preferred:
- An in-depth understanding of all aspects of toxicology, especially on DART & carcinogenicity etc.
- Experience in supporting project teams as a toxicology representative and in filing multiple INDs.
- Record of publishing in high profile scientific journals.
Current Contingent Workers apply
Not ApplicableNot Indicated
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