Senior Scientist, Study Toxicologist (Biopharma)

TL;DR

Senior Scientist, Study Toxicologist (Biopharma): Coordinating and overseeing safety pharmacology and toxicology studies at CROs to support drug development for rare diseases with an accent on study design, regulatory compliance, and data quality. Focus on managing the outsourcing process, interpreting nonclinical safety data, and preparing regulatory submission documents.

Location: Remote (US)

Salary: $133,000 - $173,000 Annual

Company

Global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Collaborate with project leads and subject matter experts to design safety pharmacology and toxicology studies.
• Act as the primary sponsor representative for CROs, managing quotes, contracts, and study timelines.
• Oversee the design, execution, and data interpretation of nonclinical safety studies.
• Review study reports and SEND datasets to ensure quality and regulatory readiness.
• Communicate study findings to senior management and resolve toxicology-related challenges.
• Contribute to nonclinical sections of regulatory documents, including INDs, NDAs, and BLAs.

Requirements

• PhD/MS with 3+ years of experience, or BS with 5+ years of toxicology experience in pharma, biotech, or CROs.
• Expertise in overseeing safety pharmacology studies.
• Proven track record of monitoring studies across various modalities (small molecules, biologics, gene therapies).
• In-depth understanding of GLP regulations and regulatory guidance for nonclinical evaluations.
• Must be based in the US (implied by domestic travel and US-specific benefits).

Nice to have

• 5+ years of hands-on experience as a study director or monitor in toxicology.
• Strong strategic thinking, critical analysis, and leadership capabilities.
• Willingness and flexibility for occasional domestic business travel (approximately 20%).

Culture & Benefits

• Comprehensive medical, dental, vision coverage, and mental health support.
• 401(k) plan with competitive company match and annual equity awards.
• Generous paid time off, fertility and family-forming benefits, and flexible work schedules.
• Access to Company Learning Institute, LinkedIn Learning, and leadership programs.
• Employee resource groups and opportunities for volunteering and community connection.