Director/Sr Director, Toxicology & Preclinical Pharmacology

Director or Senior Director, Preclinical Pharmacology/Toxicology

Responsibilities

• Lead nonclinical in vitro and in vivo pharmacology and toxicology strategies for obesity and metabolic disease programs.
• Design, monitor, and interpret GLP and non-GLP toxicology, safety pharmacology, exploratory mechanistic studies, and juvenile/reproductive toxicology programs as applicable.
• Serve as scientific lead for CRO interactions, study oversight, and data review.
• Integrate pharmacology, pharmacokinetic, toxicokinetic, pathology, and biomarker data to support lead selection, optimization, and development decisions.
• Contribute to INDs, Investigator’s Brochures, briefing books, NDAs, and other regulatory submissions.
• Collaborate with clinical and translational teams to support dose selection and risk assessment.
• Evaluate emerging literature and the competitive landscape in obesity and metabolic disease therapeutics.
• Mentor junior scientists and build scientific capabilities.
• Support strategic planning for combination and next-generation metabolic therapies.
• Other duties as assigned.

Requirements

• PhD, DVM, PharmD, or equivalent degree in Pharmacology, Toxicology, Physiology, or related discipline.
• 10+ years of experience in biotechnology or pharmaceutical industry.
• Preferred: metabolic disease pharmacology/obesity therapeutics; GLP-compliant toxicology; translational science.
• Experience supporting IND-enabling programs.
• Familiarity with ICH nonclinical guidelines and other regulatory guidance.
• Understanding of peptide therapeutics and small-molecule drug development.

Skills

• Experience with GLP-1/GIP/amylin or related metabolic pathways; combination therapies; acute/chronic toxicology; DMPK/TK interpretation.
• Prior interactions with FDA and global regulatory agencies.
• Experience managing external CRO networks and budgets.
• Ability to thrive in a fast-paced biotech environment managing multiple concurrent programs.
• Self-motivated; excellent written and verbal communication.