Clinical Development Scientist II
Cambridge, MA 
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Posted 9 days ago
Job Description
Clinical Development Scientist II

Research & Development

Cambridge, MA
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ID: 22R-74
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Full-Time/Regular

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?

The Clinical Scientist (CS) will provide clinical and scientific technical expertise and support for global clinical studies. They are responsible for working collaboratively with the Medical Director on moderately complex tasks within the categories of : 1) study design and protocol development, 2) data review and interpretation, 3) study scientific and integrity oversight, 4) safety review and communication, 5) study report, publication, and regulatory response input and review, and 6) study implementation oversight, with a focus on consistency, quality, data integrity, safety, and alignment with company objectives.

The Clinical Scientist will:

  • Assist in the timely medically and scientifically sound development of the clinical development plan
  • Contribute to clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Protocol, IB, DSUR, HA, EC, IRB responses) and contribute to regulatory submission
  • Assist in the protocol and informed consent form documents in collaboration with cross-functional facilitation in alignment with approved clinical development plan
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
  • Ensure GCP and standard operating procedures are followed
  • Monitor clinical data for specific trends as well as analyze, interpret, and author reports of scientific data from clinical studies
  • Collaborate and liaise with external partners (e.g., KMEs)
  • Close and frequent collaboration with cross-functional members including Clinical Operations, Biometrics, Safety, Regulatory and Medical Affairs

Basic Qualifications:

  • PharmD or MD, or PhD in life sciences
  • Minimum of 2 years experience in clinical research or clinical development experience
  • Knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • Scientific expertise or ability to learn in the domain of assigned study/project
  • Working knowledge of statistics, data analysis, and data interpretation

Preferred Qualifications:

  • Project management skills
  • Detail-oriented with commitment to quality
  • Ability to work cross-functionally and collaboratively is essential
  • Excellent decision-making and problem-solving capabilities.
  • Excellent communication skills, oral and written

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:

COVID 19 Vaccination: 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. Please note that it is unlikely that accommodations can be granted for customer-facing positions.

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.


Akebia is an equal oppportunity 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.


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Doctorate
Required Experience
2+ years
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