Radius Health, Inc.

  • Translational Research Manager

    Job Locations US-MA-Waltham
    Posted Date 4 weeks ago(6/25/2018 10:35 AM)
    Job ID
    2018-1800
    # of Openings
    1
    Category
    Research - Dept
  • Overview

    Radius Health, Inc. is seeking a Translational Research Manager to join our fast paced and rapidly growing research and development teams. Radius Health has a growing portfolio of projects in both oncology and osteoporosis. The successful candidate will be responsible for coordinating the activities associated with the design, execution and delivery of the clinical biomarker program, including PD biomarker assays and patient selection strategy to support clinical development.

     

    The Translational Research Manager is responsible for supporting the development of the translational research strategy in conjunction with clinical development and preclinical research teams. This role will support the operational strategy, implementation and delivery of translational research activities across programs, including clinical biomarker programs, PD biomarker assays and patient selection strategy to support clinical development. The ideal candidate should have experience in clinical sample management, biomarker analysis and clinical operations. This position will be the primary interface with external research partners and vendors and is responsible for the operations/logistics of their assigned studies. This position will seek guidance from the Clinical Development and Preclinical Research teams.

     

    Responsibilities

    • Support the development of the biomarker strategy and translational research plan to support evidence of drug-target inhibition in clinical trials and enable clinical decision making
    • Work alongside clinical operations leads on deployment of PD and patient selection assays, lab manual, clinical sample handling logistics, manage outsourcing of clinical biomarker assays
    • Contribute to regulatory filings, IND enabling data, Phase I/II/III protocols, updates to IB’s, biomarker analysis and interpretation, investigator meetings and site initiation visits
    • In collaboration with Clinical Operations, Data Management, Biostatistics, and Clinical Development Leads, develop data transfer and analysis plans
    • Create, manage and/or participate in the design of study specific project plans and supporting documents such as Gantt charts, technical manuals, source documentation and other study supplies as needed
    • Work closely with Quality Assurance and Regulatory Affairs to ensure compliance with appropriate regulatory guidelines
    • Identify, evaluate, onboard, and conduct vendor management for applicable laboratories in collaboration with Clinical Operations team

    Qualifications

     

      • MSc +8 or PhD +5 years of industry experience
      • A strong background in drug development. Clinical oncology or osteoporosis / endocrine knowledge a plus.
      • Previous experience or knowledge of endocrine therapies ER/PR and AR pathways a plus
      • Experience planning and coordinating translational research activities for drug development
      • Proven scientific leadership when working with collaborative, multi-functional teams
      • Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders
      • Demonstrated experience authoring submissions documents to regulatory agencies.

     

    Work Environment

     

    The work environment at Radius is an energetic, fast-paced, research and development environment, where most work will be performed on computers in an office environment. This position will be physically located at the Radius Headquarters in Waltham, MA. There will be some travel required from Cambridge to the Waltham site for meetings on an occasional basis. 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 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.

     

    Company Information

     

    Radius is a rapidly growing science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis and oncology, with a major focus on endocrine-mediated diseases. Radius is committed to the research and development of new therapeutics for the large and underserved osteoporosis market. The Company's lead investigational drug product candidate, abaloparatide (BA058), is in development, in both injection (Abaloparatide-SC) and transdermal (Abaloparatide-TD) methods of administration, for the potential prevention of fractures in post-menopausal women at risk of fracture from osteoporosis. A number of additional pipeline projects, including RAD1901 and RAD140, are rapidly moving forward into clinical hypothesis testing in endocrine-driven diseases.

     

    Equal Opportunity Employer Statement

    Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

     

     

     

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