Senior Toxicology Lead, Cross-Functional Drug Development

Edgewise Therapeutics; United States; On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Health benefits

Discretionary bonus

Stock options

Stock purchase plan

401(k) with match

Paid time off

Job summary

Edgewise Therapeutics in the United States is seeking a highly motivated Toxicologist to lead nonclinical safety programs for our small-molecule pipeline. You will monitor GLP and non-GLP studies, advise on safety strategy, and ensure regulatory alignment from discovery through IND-enabling stages.

Join a collaborative team and contribute to DART, genotoxicity assessment, and regulatory submissions. Strong communication and CRO-management skills are essential, with a Ph.D.

Qualifications

• Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline.
• 6+ years of relevant nonclinical/toxicology experience in pharmaceutical or biotech drug development, with demonstrated experience representing toxicology on cross-functional project teams in a matrixed environment.
• DABT certification strongly preferred.
• Direct experience with small-molecule programs; working knowledge of the different evidence streams in nonclinical safety assessment.
• Strong understanding of safety evaluation frameworks (ICH/OECD) and GLP.
• Track record designing and evaluating GLP toxicology, DART, and genotoxicity studies; CRO management.
• Strong written and oral communication skills; ability to translate complex toxicology data into clear risk-benefit guidance.
• Ability to work collaboratively across cross-functional teams and under senior leadership guidance.
• Highly organized and detail-oriented, able to manage multiple priorities.
• General scientific computer and software proficiency.

Responsibilities

• Serve as the toxicology representative on cross-functional project teams and advise on nonclinical safety strategy.
• Monitor GLP and non-GLP toxicology studies at CRO facilities and oversee day-to-day study conduct.
• Design, oversee, and interpret GLP/non-GLP toxicology studies in IND/CTA-enabling packages.
• Review study protocols, in-life data, and draft reports for regulatory compliance.
• Coordinate with CROs on timelines, deviations, and data quality issues.
• Track study timelines and deliverables across the lifecycle and report status to teams.
• Collaborate with Pharmacology, DMPK, CMC, Regulatory Affairs, Clinical Development, and PM.
• Summarize nonclinical safety data for leadership review.
• Author safety pharmacology/toxicology sections of regulatory documents (INDs, etc.).
• Attend scientific meetings to maintain and grow toxicology expertise.
• Adhere to safety policies and perform other duties as assigned.

Skills

Cross-functional collaboration

Written and verbal communication

Project leadership

Regulatory understanding

Education

Ph.D. in toxicology or related field

Job description

Edgewise Therapeutics in the United States is seeking a highly motivated Toxicologist to lead nonclinical safety programs for our small-molecule pipeline. You will monitor GLP and non-GLP studies, advise on safety strategy, and ensure regulatory alignment from discovery through IND-enabling stages.

Join a collaborative team and contribute to DART, genotoxicity assessment, and regulatory submissions. Strong communication and CRO-management skills are essential, with a Ph.D.