Director, Nonclinical Safety — Strategy & Leadership

Nimbus Therapeutics; Boston (MA); On-site; USD 225,000 - 285,000; Full time

Job summary

The role interfaces with CMC, Clinical, Medical, Regulatory Affairs, and Program teams to shape data generation, support IND/CTA filings, and guide development of small molecule candidates.

Successful candidates bring deep toxicology leadership, strong communication, and a track record of delivering high-quality safety programs in a fast-paced biotech environment.

Qualifications

• PhD in Toxicology/Pathology or DVM with ~10 years in pharma toxicology
• Master’s in Toxicology/Pathology or DVM with ~15 years in pharma toxicology
• Strong leadership and CRO/vendor management experience
• Deep understanding of GLP regulatory requirements and FDA interactions
• Attention to detail, quality, and compliance
• Excellent verbal and written communication with cross-functional teams
• Ability to navigate, problem-solve, and lead in a dynamic, fast-paced environment

Responsibilities

• Develop strategic nonclinical toxicology development plans across programs
• Collaborate with CMC, Clinical, Medical, and Regulatory to shape data generation for IND/CTA filings
• Represent Nonclinical Safety at cross-functional project teams
• Oversee design and execution of GLP and non-GLP safety studies
• Manage CROs, budgets, and timelines for safety studies
• Prepare discussions for FDA and ensure regulatory compliance

Skills

Leadership

People management

CRO management

Verbal communication

Written communication

Attention to detail

Problem solving

Adaptability

Education

PhD Toxicology/Pathology or DVM

Master’s Toxicology/Pathology or DVM

Job description

The role interfaces with CMC, Clinical, Medical, Regulatory Affairs, and Program teams to shape data generation, support IND/CTA filings, and guide development of small molecule candidates.

Successful candidates bring deep toxicology leadership, strong communication, and a track record of delivering high-quality safety programs in a fast-paced biotech environment.