Principal Scientist/ Associate Director, Toxicology

Edgewise Therapeutics

7h•$150,000 - $200,000

About The Position

Edgewise is seeking a highly motivated, scientifically rigorous Toxicologist to serve as the toxicology representative on cross-functional project teams supporting its small-molecule pipeline. Under the direction of senior toxicology leadership, this individual will monitor and execute nonclinical safety programs, ensuring that GLP and non-GLP safety evaluation studies—from discovery through IND-enabling studies and registration—meet high scientific and quality standards, satisfy regulatory expectations, and support timely clinical development.

Requirements

Ph.D. in toxicology, pharmacology, physiology, biology, or a related discipline.
At least 6 years of relevant nonclinical/toxicology experience in pharmaceutical or biotech drug development.
Demonstrated experience representing toxicology on cross-functional project teams in a matrixed environment.
Direct experience with small-molecule programs and working knowledge of the different evidence streams in nonclinical safety assessment.
Strong understanding of the applicable safety evaluation framework, including applicable ICH and OECD guidelines, and GLP.
Track record designing and critically evaluating GLP toxicology, DART, and genotoxicity studies, and managing CRO relationships and deliverables.
Strong written and oral communication skills, including the ability to translate complex toxicology data into clear risk-benefit guidance for non-toxicologist stakeholders.
Ability to collaborate across cross-functional teams and work under the guidance of senior toxicology leadership.
Highly organized and detail-oriented, with the ability to manage multiple priorities.
General scientific computer and software application proficiency.

Nice To Haves

DABT certification is strongly preferred.

Responsibilities

Represent toxicology on one or more cross-functional project teams and advise on nonclinical safety strategy from discovery through all phases of clinical development.
Actively participate in cross-functional team meetings.
Serve as study monitor for GLP and non-GLP nonclinical toxicology and safety pharmacology studies, overseeing day-to-day study conduct at CRO facilities.
Design, oversee, and interpret GLP and non-GLP toxicology studies, including general toxicology, DART, genotoxicity, safety pharmacology, and carcinogenicity assessment as applicable, in support of IND/CTA-enabling packages and lifecycle development.
Review and provide scientific input on study protocols, in-life data, and draft reports, ensuring scientific accuracy, quality, and regulatory compliance.
Identify and troubleshoot study-level and program-level toxicology issues, escalating and resolving cross-functional conflicts to keep programs on timeline.
Coordinate with CROs on study timelines, deviations, and data quality issues, escalating significant findings to senior toxicology leadership.
Work with the program coordinator to track study timelines and deliverables across the study lifecycle and communicate status to program teams.
Collaborate with Pharmacology, DMPK, CMC, Regulatory Affairs, Clinical Development, and Project Management.
Critically analyze, interpret, and summarize nonclinical safety data for program teams and senior leadership.
Author safety pharmacology and toxicology sections of global regulatory documents, such as INDs, Investigator Brochures, briefing books, annual reports, and DSURs, under the direction of senior toxicology leadership.
Maintain scientific acumen by attending relevant scientific meetings, participating in educational opportunities, maintaining professional networks, and participating in professional organizations.
Read, understand, and comply with workplace health and safety policies, safe work practices, and company policies and procedures.
Perform other duties as assigned by the supervisor.