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Director of Toxicology

Company: Nuvalent
Location: Cambridge
Posted on: January 13, 2021

Job Description:

Director of ToxicologyUS-MA-CambridgeJob ID: 2Type: Regular Full-Time# of Openings: 1Category: Research & DevelopmentNuvalentOverview As a key member of the Nuvalent development team, the Director of Toxicology will report to the Vice President of Translational Development and is responsible for overseeing the overall strategy, design, analysis interpretation and reporting of Safety Pharmacology and Toxicology data for discovery and development programs. In addition, the individual will liaise with Research and Development colleagues to develop overall safety pharmacology and toxicology development strategies, and represent translational development on discovery and development teams. With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Nuvalent is funded by Deerfield Management. Responsibilities Essential Job Functions

  • Design, implement, drive, and oversee toxicology strategies for portfolio assets
  • Work with internal teams and external partners to execute on development team objectives
  • Contribute to development program strategy, study execution, data review/analysis, study reports, protocol preparation and regulatory document preparation; write and review non-clinical toxicology summary documents
  • Oversees vendors and consultants as appropriate to execute on toxicology studies
  • Will report findings and advise the Product Development Team on Preclinical Safety of development candidates
  • Lead authorship for toxicology sections for regulatory documents. Lead the resolution of toxicology-related queries from drug regulatory agencies, writing and reviewing responses to regulatory on toxicology-related queries Qualifications Key Qualifications
    • PhD in Toxicology, Pharmaceutical Sciences, DVM or related field is required
    • DABT certification is highly desired
    • A minimum of 10 years' experience in the life science industry in a Toxicology role and proven track record of conducting drug safety assessment studies, and ability to make sound risk assessments and represent toxicology perspectives on project teams and with external partners
    • Direct experience developing the toxicology strategy and data package supporting the clinical development of small molecule therapeutics
    • Track record of toxicology leadership on multiple programs at early and late stages of development
    • Firm understanding of pharmacokinetics and modeling human dosing
    • Experience with EMA and FDA CTA/IND and BLA submissions and regulatory interactions
    • Experience partnering with DMPK, Regulatory Affairs, Clinical, CMC and Translational Science colleagues to ensure comprehensive Toxicology approaches are developed as part of the program strategy
    • Extensive experience working with strategic outsourcing and study coordination
    • Ability to perform in fast-paced, dynamic, constantly evolving environment
    • Excellent communication and organizational skills and attention to detail
    • Strong time management skills; ability to prioritize multiple tasks efficiently Nuvalent, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI

Keywords: Nuvalent, Cambridge , Director of Toxicology, Executive , Cambridge, Massachusetts

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