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Summer Intern: Clinical Development

Akebia Therapeutics

Summer Intern: Clinical Development

Cambridge, MA
Internship
Paid
  • Responsibilities

    Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

    At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.  Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

    This is life-changing work, and we are all in, are you?

    Clinical Development Department at Akebia Therapeutics is seeking an intern to be play an integral role in many ongoing activities. This opportunity shall serve as a learning opportunity to drug development in the pharmaceutical industry. The intern will be exposed to clinical trials design, execution as well as involvement in post-NDA activities. Although being based within Clinical Development, cross-functional activities may include interactions with Biostatistics, Drug Safety and Pharmacovigilance, Regulatory Affairs and Clinical Operations.

     

    Required Skills

    • Participate in the development and quality review of study protocols, protocol synopses, abstracts, clinical data presentations, and manuscripts
    • Retrieve, synthesize and interpret the scientific literature and generate evidence as needed
    • Support medical monitoring activities of ongoing clinical trial
    • Support candidate selection for the new trials
    • Assist in the preparation of clinical development presentations used at internal and external meeting forums
    • Participate in reviewing, summarizing, and presenting clinical trials results from TLFs of completed and ongoing trials.
    • Participate in weekly 1 on 1 meetings with the clinical development mentor
    • Present an intern experience presentation at end of program

    Required Experience

    BASIC QUALIFICATIONS:

    • Advanced degree (MD, PhD, Masters) preferred. Master and doctoral candidates who have at least 3-5 years of clinical research experience are welcome to apply
    • Experience in clinical trials, epidemiologic or clinical research is required
    • Master and doctoral candidates, GPA of 3.0 or above is required
    • Must have completed at least 20 credit hours of epidemiology, biostatistics, data analysis or other related coursework.
    • Must be legally authorized to work in the United States

     PREFERRED QUALIFICATIONS:

    • Experience with chronic kidney disease is preferred
    • Self-initiative, can-do attitude, independent and ability to meet deadlines in a fast-paced environment
    • Strong quantitative and analytical skills
    • Solid understanding of different study designs particularly clinical trials
    • Ability to review large number of complex output tables and synthesize conclusions in scientific and informative summary
    • Strong written and verbal communication skills

     

     ARE YOU AN AKEBIAN?

    An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian’s aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian’s believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

     All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.  

     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.

    #LI-DNI

  • Qualifications
    • Participate in the development and quality review of study protocols, protocol synopses, abstracts, clinical data presentations, and manuscripts
    • Retrieve, synthesize and interpret the scientific literature and generate evidence as needed
    • Support medical monitoring activities of ongoing clinical trial
    • Support candidate selection for the new trials
    • Assist in the preparation of clinical development presentations used at internal and external meeting forums
    • Participate in reviewing, summarizing, and presenting clinical trials results from TLFs of completed and ongoing trials.
    • Participate in weekly 1 on 1 meetings with the clinical development mentor
    • Present an intern experience presentation at end of program
  • Industry
    Transportation / Trucking / Railroad