Associate Director, Toxicology

Company: Cytokinetics
Location: San Francisco
Posted on: March 22, 2025

Job Description:

Associate Director, ToxicologyAssociate Director, ToxicologyApply locations South San Francisco, California time type Full time posted on Posted 8 Days Ago job requisition id R67Cytokinetics 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 as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.Job Description:Cytokinetics was founded by four pioneers in cell biology whose academic research and discoveries contributed to the scientific platform for our company. For more than 25 years, our scientists have built on their seminal work to pioneer potential medicines targeting muscle function. Today, we continue to look for tenacious scientists who are driven to push the boundaries of innovation for the benefit of patients.Job purposeAs the Associate Director of Toxicology, you will play a critical role in advancing our innovative drug discovery and development programs by providing expert guidance and hands-on toxicology and safety pharmacology support. In this highly impactful position, you will have the opportunity to apply your deep toxicology knowledge and industry experience to design and manage non-clinical safety studies, provide strategic input to project teams, and ensure the highest standards of scientific and ethical conduct. You will be an integral member of cross-functional teams, collaborating closely with colleagues in Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical to drive our programs forward.Your strong analytical skills, decisiveness, and goal-oriented approach will be key to meeting timelines while upholding scientific excellence. In this role, you will also oversee contracts, budgets and CRO relationships for outsourced toxicology studies. Your regulatory expertise will be leveraged to provide high-quality, submission-ready documentation for regulatory filings.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
  • 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.If you are passionate about applying your toxicology expertise to develop life-changing therapies across Muscle Biology research and development, we encourage you to apply for this exciting opportunity to make an impact as a key member of the Cytokinetics team.Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
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Keywords: Cytokinetics, San Francisco , Associate Director, Toxicology, Executive , San Francisco, California