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.
- Improve and maintain scientific acumen in the field of toxicology by attending relevant scientific meetings (e.g., ACT, SOT); participating in educational opportunities; maintaining professional networks; and participating in professional organizations.
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
- Perform other duties as assigned by supervisor.
Required Education, Experience and Skills:
- 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 the applicable safety evaluation framework (e.g., 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; ability to translate complex toxicology data into clear risk-benefit guidance for non-toxicologist stakeholders.
- Ability to work collaboratively across cross-functional teams and under the guidance of the senior toxicology leadership.
- Highly organized and detailed oriented individual capable of managing multiple priorities.
- General scientific computer and software application proficiency.
Salary range: $150,000-$200,000, title and salary commensurate with experience.
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.