Description

You will lead nonclinical safety strategies for small molecule degrader programs from discovery through clinical development. You'll design and oversee toxicology and safety pharmacology studies, prepare regulatory documents, and collaborate with cross-functional teams to drive integrated program decisions.

Requirements

• PhD in Toxicology, Pharmacology, DVM, or related field; DABT or ERT certification preferred
• 12+ years biopharma experience in Toxicology or Pathology
• 5+ years leading preclinical development strategy for IND-through-Phase II programs
• Experience with EMA and FDA CTA/IND submissions and regulatory interactions
• Strong communication skills and ability to work in fast-paced environment

Responsibilities

• Provide expert nonclinical safety support for degrader projects from discovery to clinical programs
• Act as key nonclinical safety representative on cross-functional development teams
• Develop nonclinical safety strategies and plans for all stages of drug development
• Oversee toxicology and safety pharmacology studies at CROs, including GLP/non-GLP studies
• Lead authorship of toxicology sections of regulatory documents (IND, IB, etc.)