Primary Responsibilities:
? Provide preclinical safety expertise and strategy for pre-clinical and clinical development programs from pre-clinical drug candidate selection to IND enabling and clinical trials
? Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support drug development of biopharmaceuticals
? Ensure that the preclinical safety plan is aligned with the clinical development plan and regulatory guidelines (ICH, FDA, GLP, etc.)
? Serve as Preclinical Safety team leader for multiple programs and contribute to the program’s goals and deliverables
? Identify and manage contract research laboratories (CRO) for preclinical safety studies; review reports; ensure they are using systems and processes in compliance with all relevant regulatory standards
? Write and review documents for INDs / regulatory section submissions; represent the company as the pre-clinical toxicology expert before regulatory authorities
? Serve as a subject matter expert to provide input for due diligence of potential external partnership programs
Qualifications:
? 10+ years of combined toxicology, drug development and regulatory experience in a biotech, biopharmaceutical or CRO setting
? Extensive knowledge and expertise with in vitro and in vivo toxicology study conduct and reporting
? Familiar with applicable regulatory guidelines; prior experience with regulatory agency interactions is preferred
? Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external experts for the conduct of toxicology studies
? Good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts
Education:
? Ph.D. or equivalent in Toxicology or closely related field
? Toxicology board certification is a plus
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