Radius Health, Inc.

  • Director, Clinical Development

    Job Locations US-MA-Waltham
    Posted Date 1 month ago(10/16/2018 3:01 PM)
    Job ID
    2018-1846
    # of Openings
    1
    Category
    Clinical Dev - Dept
  • Overview

    The Director, Clinical Development, designs and implements clinical trials, including writing medical protocols, creatively working to assess appropriate endpoints and interfacing with Clinical Operations to implement trials. The incumbent would work closely with biometrics group and clinical operations to assure accuracy of clinical data and robustness of study outcomes.

    Responsibilities

    • Integrates relevant scientific findings from the project and literature to facilitate research and overcome scientific challenges.
    • Designs and implement clinical trials, including writing protocols, creatively working to assess appropriate endpoints, and interfacing with Clinical Operations to implement trials.
    • Interprets data, assesses integrity of data, and provides scientific summaries.
    • Works closely with biometrics group and clinical operations to assure accuracy of clinical data and robustness of study outcomes.
    • Works closely with Project Head, CSO, Research, Clinical and other project team members to achieve the scientific goals.
    • Identifies CROs or other collaborations that further scientific objectives or apply expertise that is not available in-house.
    • Assists Life Cycle Management, regulatory submission activities, and indication development.
    • Collaborates with, monitor and report CRO based study results to the project team.

    Qualifications

    • PhD or MD with at least 5 years’ clinical trial experience preferred; a Bachelors or Masters in a scientific discipline with at least 10 years’ directly relevant industry experience is required.
    • A deep understanding of oncology drug development 
    • Demonstrated expertise in the design, authoring and successful implementation of clinical protocols and clinical study reports.
    • Strong experience reviewing & interpreting study data/reports and presenting findings to project team members.
    • Excellent organizational, written and oral communications skills.
    • Demonstrated experience in scientific writing.
    • Proven experience working in cross-functional teams is required
    • Experience across the range of early and late stage clinical development is preferred.

     

    Work Environment:

     

    The work is performed in a typical office environment with heavy computer duties.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet.   Frequent travel required.

    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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