Principal Scientist/ Associate Director, Toxicology

About the role

At Edgewise, we are focused on advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. Leveraging our expertise in muscle biology and small molecule drug development, we are building a cardiovascular pipeline that includes programs for hypertrophic cardiomyopathy, heart failure and other serious cardiovascular diseases.

We’re building a passionate, experienced team committed to tackling complex scientific and clinical challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you.

About the Position:

We are seeking a highly motivated, scientifically rigorous Toxicologist to serve as the toxicology representative on cross-functional project teams supporting our small-molecule pipeline. This individual will be responsible for hands-on study monitoring and execution of the company's nonclinical safety programs under the direction of senior toxicology leadership to ensure GLP and non-GLP safety evaluation studies from discovery through IND-enabling studies and registration, are conducted to the highest scientific and quality standards in order to consistently meet regulatory expectations and support timely clinical development

Essential Job Duties and Functions:

- Serve as the toxicology representative on one or more cross-functional project teams, advising on nonclinical safety strategy from discovery through all phases of clinical development. Actively participates to 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 (general tox, DART, genotoxicity, safety pharmacology, carcinogenicity assessment as applicable) in support of IND/CTA-enabling packages and lifecycle development. Ensure alignment within the function.

- Review and provide scientific input on study protocols, in-life data, and draft reports. Ensure 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 closely with CROs on study timelines, deviations, and data quality issues, escalating significant findings to senior toxicology leadership.

- In collaboration with the program coordinator, track study timelines, and deliverables across the study lifecycle and communicate status to program teams.

- Works closely with other functions such as Pharmacology, DMPK, CMC, Regulatory Affairs, Clinical Development, and Project Management.

- Critically analyzes, interprets, and summarizes nonclinical safety data for review by program teams and senior leadership.

- Author safety pharmacology and toxicology sections of global regulatory documents (e.g., INDs, Investigator Brochures, briefing books, annual reports, DSURs) under the direction of the senior toxicology leadership.