Director, Nonclinical Safety Assessment Expert – Therapeutic

Responsibilities

• Provide global, end‑to‑end nonclinical safety leadership across multiple therapeutic areas and modalities.
• Serve as the primary Preclinical Safety (PCS) authority on cross‑functional R&D teams and in interactions with global Health Authorities.
• Lead PCS Target Teams to design, integrate, interpret, and apply nonclinical safety assessment programs.
• Represent Preclinical Safety on cross‑functional R&D project teams.
• Define and implement fit‑for‑purpose, modality‑appropriate nonclinical programs in collaboration with PCS and external line functions.
• Lead global Health Authority interactions, including negotiation on safety issues and scientific interpretation.
• Author nonclinical safety sections of internal and regulatory documents.
• Drive and coordinate communication strategies between PCS and R&D project teams.
• Mentor and coach colleagues on drug development strategy.

• Advanced scientific degree (PhD, MD, DVM, PharmD, or equivalent) in Toxicology, Pharmacology, or related discipline; or DABT; or equivalent industry experience.
• 5+ years of experience as a nonclinical safety Project Team member, preferably across multiple development phases up to registration.
• 8 or more years of experience in nonclinical drug development (e.g., project toxicologist, pharmacologist, study director).
• Demonstrated expertise across multiple modalities (e.g., small molecules, biotherapeutics, oligonucleotides) and their safety considerations.
• Proven track record of direct interaction with global Health Authorities, including shaping regulatory strategy and submission writing.
• Recognized scientific and regulatory expertise in nonclinical safety assessment within a global drug development context.
• Demonstrated leadership and influence in complex, matrix‑managed, international project environments.
• Strong problem‑solving capability in multidisciplinary, project‑driven settings.