自贡招聘

The Toxicology Director/Sr Manager will report to VP of DMPK. The successful candidate will be responsible and accountable safety strategy and for design and supervising of all safety studies from discovery to early/late development projects. S/He will manage all interactions with vendors and ensure delivery of study results and reports consistent with project timeline. Additionally, s/he will be accountable for the delivery of proper documents for regulatory filings.

Key Responsibilities:

- Oversees nonclinical Tox related project activities for the company from discovery stage through regulatory filings and commercialization.
- Develops and oversees execution of phase appropriate nonclinical safety strategy & integrated project plans including milestones, timelines, resources and budgets.
- Serve as a subject matter expert for GLP, non-GLP, and safety pharmacology studies. Ensure appropriate expertise is available to represent the company as the nonclinical safety expert before regulatory authorities
- Accountable for delivery of audited and timely delivery of high-quality safety reports to enable clinical plans and regulatory filing submissions in multiple markets.
- Identify, lead, manage, and build a long-term relationship with CROs for delivery of nonclinical safety studies for pharmaceutical and nutraceutical candidates.
- Accountable for all safety associated regulatory and quality documents associated with INDs, NDAs and other regulatory submissions and documentation; represent the company as the nonclinical safety expert before U.S. and European regulatory authorities
- Sets high standards for compliance to meet or exceed regulatory requirements both internally and by ensuring CROs are using systems and processes in compliance with all relevant regulatory standards.
- Ensures effective communication and collaboration of all involved functions and third parties.

Qualifications / Experience:

- PhD in Pharmacology, Biology, Toxicology, or related scientific discipline
- 5+years of experience in a pharmaceutical or biotechnology management of nonclinical toxicology activities for discovery and development programs
- Broad understanding of all aspects of nonclinical safety and experienced with regulatory filings; thorough knowledge of relevant FDA and EMEA regulations
- Extensive experience in working with and managing US and International CROs for protocol design and study execution
- Fluent in English and Chinese. Working experience abroad is a plus.

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