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Location: Thousand Oaks, CA (Relocation provided), or West Coast with bi-weekly travel
About the Role:
An exciting opportunity to lead cutting-edge toxicology initiatives in a dynamic, privately held biotech company. With two INDs and one NDA on the horizon, this role offers unparalleled opportunities to make a significant impact while expanding your CV with high-profile projects.
Key Responsibilities:
Lead toxicology efforts with a focus on small molecule development
Author and review toxicology documents for IND and NDA submissions
Oversee CROs conducting toxicology studies, ensuring compliance and quality
Collaborate cross-functionally to drive project timelines and regulatory submissions
Must-Have Qualifications:
DABT certification
Strong background in small molecule toxicology
Proven experience with IND and NDA submissions, including document authorship
Extensive CRO oversight experience
PhD in a relevant field (Exceptional candidates with DABT certification and no PhD will also be considered)
Nice-to-Have Qualifications:
Experience in Neurology, Rare Disease, Immunology, or Cardiovascular therapeutic areas
Background in Pathology
DVM degree is highly desirable
What We’re Looking For:
Independent contributor with strong vendor management skills
Not suited for candidates from big pharma with extensive people management responsibilities
Preference for professionals from small biotech companies with successful NDA submissions