Senior Director, Toxicology
Core
Lead preclinical safety programs and toxicology strategy to advance biologic therapeutics through all stages of drug development.
Role type
Senior Director, Toxicology (Strategy & Management)
Builds
Preclinical safety programs for new biologic products
Domain
Biopharmaceuticals / Toxicology / Drug Development
Required skills
toxicology, pharmacology, biologic therapeutics development, regulatory document writing, global regulatory communication, SOP development, staff mentoring, hiring
Preferred skills
Board Certification in Toxicology
Technologies
N/A
Responsibilities
Design and implement preclinical safety programs; communicate project status to line management; write and review regulatory documents (INDs, BLAs); communicate with global regulatory authorities; maintain external contacts with CROs and agencies; provide consultative toxicology support; develop and maintain SOPs; mentor and supervise junior staff; recruit and hire scientific staff
Seniority
Director, strategic leadership with hands-on scientific input