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