岗位描述
岗位职责
• Act as the principal scientific/regulatory lead for FDA, global agencies, and key clients.
• Partner with executive leadership to drive growth, operational excellence, and market expansion.
• Oversee quality, compliance, and delivery of nonclinical programs (pharmacology, DMPK, safety).
• Support business development with scientific and regulatory expertise.
• Represent InnoStar at industry conferences to build brand and credibility.
• Develop and execute FDA-aligned scientific and regulatory strategy.
岗位要求
• PhD in Toxicology, Pharmacology, Pharmaceutical Sciences, or related field.
• 8–10+ years as a nonclinical reviewer at FDA (CDER/CBER).
• Deep knowledge of FDA requirements, IND/NDA/BLA, GLP, ICH guidelines.
• 15+ years total pharma/CRO experience with senior leadership experience (VP/CSO/Head).
• Track record of successful FDA interactions and IND approvals.
• English fluent; Chinese a strong plus.
• DABT certification highly preferred.