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Sales Associate

Akebia Therapeutics

Sales Associate

Cambridge, MA
Full Time
Paid
  • Responsibilities

    The Scientist I, Toxicology is responsible for overseeing non-clinical toxicology studies to advance drug candidates from preclinical through clinical development.  The ability to plan, execute, monitor and interpret toxicology studies for advancing therapeutic candidates through all stages of discovery and development are crucial elements of this position.   These activities may also include the development of nonclinical sections for IND, IB, and NDA submissions as well as interactions with regulatory agencies. Excellent interpersonal and communication skills are essential in this highly visible role to effectively work within the cross-functional program teams. 

    Required Skills

    The successful candidate will:

    • Work closely with program leaders, Research & Development, DMPK, Regulatory, and Clinical groups to design a toxicology development plan that supports candidate molecules from lead optimization into Phase I clinical trials and beyond.
    • Support and/or lead the safety assessment of impurities and formulations.
    • Craft safety assessments for novel and existing pharmacological targets within the Akebia portfolio and customize discovery and investigative toxicological efforts to address possible liabilities.
    • Assist in the design and conduct of investigative toxicology studies.
    • Communicate toxicology results to cross functional program teams and to the broader organization, as needed.
    • Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization and monitor study activities.
    • Assist in the writing of regulatory submissions (INDs, DSURs, IBs, and NDAs).
    • Maintain a current understanding of toxicology literature, methodology and regulatory requirements.

    Required Experience

    BASIC QUALIFICATIONS:

    • Ph. D. in Toxicology or a closely related discipline
    • 0-2 years’ experience as a Study Director on nonGLP and GLP studies for small molecules.

     

     

    PREFERRED QUALIFICATIONS:

    • DABT board certification
    • Experience in designing, monitoring, and interpreting toxicology studies to support clinical development of candidate therapeutic agents.
    • Strong communication and interpersonal skills with an ability to effectively function within a matrixed environment.
    • Critical problem solving and organizational skills required.

     

     

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

     

    Akebia is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

     

  • Qualifications

    The successful candidate will:

    • Work closely with program leaders, Research & Development, DMPK, Regulatory, and Clinical groups to design a toxicology development plan that supports candidate molecules from lead optimization into Phase I clinical trials and beyond.
    • Support and/or lead the safety assessment of impurities and formulations.
    • Craft safety assessments for novel and existing pharmacological targets within the Akebia portfolio and customize discovery and investigative toxicological efforts to address possible liabilities.
    • Assist in the design and conduct of investigative toxicology studies.
    • Communicate toxicology results to cross functional program teams and to the broader organization, as needed.
    • Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization and monitor study activities.
    • Assist in the writing of regulatory submissions (INDs, DSURs, IBs, and NDAs).
    • Maintain a current understanding of toxicology literature, methodology and regulatory requirements.
  • Industry
    Transportation / Trucking / Railroad