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Director, Nonclinical Safety Sciences

Company: Horizon Therapeutics
Location: Reston
Posted on: November 20, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

As a Director of Nonclinical Safety Sciences at Horizon Therapeutics you will provide regulatory toxicology leadership oversight and mentoring for the non-clinical toxicology group. This role will support both early and late-stage toxicology aspects of the portfolio and will bring strategic drug development input to Horizon Management Leaders. D emonstrated expertise in drug development working across a cross-functional environment to advance decisions for programs in the interest of safety is critical for this role. Experience in authorship of NDAs, BLAs and interacting with regulatory authorities and late-stage teams to achieve product registrations internationally is preferred. This individual will also contribute to developing Research goals and strategies for advancing safe early-stage drug candidates to IND-enabling phase toxicology studies. The Director will be a functional expert for Nonclinical Safety and Regulatory Toxicology, participate in due diligence activities on behalf of Horizon and lead external collaborations with partner companies.

Responsibilities:

  • Provide leadership and oversight, mentor, and foster growth of a non-clinical toxicology group at Horizon
  • Ensure representation of toxicology on all project teams as needed by supporting and oversight of a toxicology group
  • Contribute and participate in decision-making with other Horizon Senior Management Leadership as the senior subject matter expert
  • Represent the non-clinical safety interests at Governance and senior leadership meetings
  • Ensure department budgeting and forecasting of out-sourced study needs
  • Provide regulatory tox strategy input for research and late-stage project teams
  • Provide internal and external toxicology representation and foster contract research organization relationships to progress therapeutics through the development pipeline as needed
  • Contribute and participate in decision-making with other Horizon Senior Management Leadership as the senior subject matter expert
  • Contribute to due diligence reviews and decisions
  • Review and approve toxicology documents US and ex-US regulatory submissions (eg. IND, CTA, NDA/BLA, briefing books, Investigator Brochures etc). Provide authorship as needed.
  • Possess a working knowledge of the code of federal regulations for toxicology(eg. CFR 21 Part 58 etc) and regulatory guidance's for drug development

    Qualifications and Skills Required:
    • PhD in Pharmacology or Toxicology with DABT certification with minimum of 10years of experience leading a department of toxicologists.
    • An in-depth understanding of regulatory toxicology strategy for small molecules and biologics
    • Proven ability to lead, collaborate and motivate departments to achieve cross functional goals
    • Demonstrated ability to build strong relationships and leverage internal and external partners to deploy resources and programs that positively impact the business.
    • Attention to detail, demand for quality, and sense of passion and urgency to achieve goals and improve the lives of patients.
    • Proficient in all communication skills (written and verbal) and technologies supporting (Word, Sharepoint etc)
    • Professional, proactive demeanor.
    • Strong interpersonal skills.

      Horizon Core Values & Competencies:

      Growth
      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Cultivates Innovation
      • Develops Talent

        Accountability
        • Drives Results
        • Ensures Accountability
        • Decision Quality

          Transparency
          • Courage
          • Collaboration
          • Instills Trust

            Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department. Associated topics: aseptic, biopharmaceutical, drug development, food scientist, health, histologist, immunoassay, transfection, trauma, virus

Keywords: Horizon Therapeutics, Reston , Director, Nonclinical Safety Sciences, Executive , Reston, Virginia

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