Radius Health, Inc.

  • Associate Director Safety Toxicology

    Job Locations US-MA-Waltham
    Posted Date 1 month ago(4/19/2018 1:34 PM)
    Job ID
    2018-1750
    # of Openings
    1
    Category
    Research - Dept
  • Overview

    The Associate Director Safety Toxicology will have broad expertise in safety toxicology/pharmacology and will contribute to a number of preclinical projects as well as support ongoing and late stage programs in the clinic. In this position, you will be accountable for the timely and effective drug safety support for programs from preclinical through marketed products. You will have the opportunity to play a key role as the safety pharmacology lead to develop and implement the overall safety pharmacology strategy and deliver data for projects targeting patients with life threatening diseases.

    Responsibilities

    • Lead the Safety strategy for the Radius early and late stage development programs
    • Develop, design, implement overall safety pharmacology strategy and studies for Radius oncology programs
    • Work cross-functionally with project teams and CRO’s to bring toxicology data and expertise to interactions with Regulatory agencies, Health Authorities and internal stakeholders.
    • Responsible for the safety components of pharmacokinetic (PK-PD) modeling and toxicokinetic safety exposure modeling for clinical development and regulatory discussions.
    • Drive data interpretation and deliver data summaries to support electronic document submissions (eCTD) for Food and Drug Administration (FDA) submissions, and European nonclinical & regulatory documents for MAA submissions and other registration dossiers.

    Qualifications

    • Masters /PhD preferred
    • 5+ years and a deep knowledge of drug development, including nonclinical toxicology, pharmacokinetics, and/or pharmacology
    • Experience overseeing key aspects of the toxicology activities in pharmaceutical development
    • Knowledge of the FDA and ICH guidelines pertaining to new chemical entity development and regulatory submissions to global health authorities, including contributions to Common Technical Documents (eCTD) submissions, Investigational New Drug (IND), New Drug Application (NDA), and European Marketing Authorization Applications (MAA).
    • Excellent scientific writing and verbal communication skills. Demonstrated ability to integrate and analyze complicated data sets.

     

    • Work Environment

      The work environment at Radius is an energetic, fast-paced, research and development environment, where most work is performed on computers in a typical office environment. The noise level in the work environment is usually quiet. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

       

      While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 

       

      Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

     

     

     

     

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