Cytokinetics · 2 weeks ago
Associate Director, Toxicology
San Francisco Bay Area
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$200K/yr - $221K/yr
7+ years expCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors. The Associate Director of Toxicology will provide expert guidance and support for drug discovery and development programs, managing safety studies and collaborating with cross-functional teams.
BiopharmaBiotechnologyHealth Care
Responsibilities
Apply your extensive toxicology expertise to design, manage, analyze, interpret and report on safety pharmacology and toxicology studies, including general toxicology, genetic toxicology, developmental & reproductive toxicology (DART), as well as toxicokinetics
Draft, review and approve toxicology study protocols, reports, associated nonclinical summaries, regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication
Provide strategic toxicological assessments and preclinical guidance to project teams and senior management to inform key program decisions and clinical/regulatory strategies
Oversee contracts, budgets and CRO relationships for outsourced toxicology/safety pharmacology studies to ensure the highest standards of scientific and ethical conduct
Maintain up-to-date toxicology plans for all IND and NDA enabling projects/programs including listings of studies, timelines, status, and costs; update and refine as necessary
Assess the risk of drug candidates on reproductive health, particularly in relation to exposure levels and durations
Leverage your regulatory expertise to provide high-quality, submission-ready documentation for interactions with health authorities
Qualification
Required
PhD in Toxicology or related health discipline with 7+ years of industry-related experience in regulatory toxicology in the conduct of regulatory submissions; DABT certification a plus
Extensive hands-on experience in all facets of toxicology study conduct with a proven track record of conducting preclinical drug safety assessments; an emphasis on developmental and reproductive toxicology is a plus
Experience in outsourcing and external oversight of nonclinical toxicology studies conducted by qualified CROs
Deep knowledge of global regulatory requirements for non-clinical safety packages across all phases of development; Experience in working with U.S. and European regulatory authorities
Excellent communication skills to present complex scientific information to diverse audiences and author regulatory documents and scientific publications
Ability to make risk assessments and represent toxicology perspectives on project teams and with external partners
Company
Cytokinetics
Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.
501-1000 employees
H1B Sponsorship
Cytokinetics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (9)
2023 (4)
2022 (6)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$2.41BKey Investors
Royalty PharmaDeerfieldVulcan
2025-09-16Post Ipo Debt· $650M
2024-05-22Post Ipo Equity· $550M
2024-05-22Post Ipo Debt· $50M
Leadership Team
Robert Blum
President & CEO
Sung Lee
EVP & CFO
Recent News
Medical Xpress - latest medical and health news stories
2026-01-06
Company data provided by crunchbase