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 Director of Standards and Compliance provides leadership and operational oversight of the development and implementation of SOPs, training and compliance for the clinical and related functions within the R&D organization including Biometrics, Clinical Development, Clinical Operations, Medical Writing, Pharmacovigilance, Regulatory etc). Establishes the vision and strategy for innovative and effective business processes and associated learning programs in support of clinical trial execution. Ensures inspection readiness and compliance for the clinical organization. Establishes best practices in process ownership and development.
Responsible and accountable for establishing operational standards and managing a quality-oriented platform to deliver associated learning programs for conducting development programs and tracking and trending compliance. This platform includes coordinating the development of standard procedures affecting the organization within established time frames and compliant with applicable clinical and regulatory guidelines and practices.
The Director, Standards and Compliance is a strategic partner with functional and executive leadership to establish and maintain alignment with business vision, objectives and priorities. The Director, Standards and Compliance works with cross functional teams to develop appropriate policies, procedures, systems, and tools to ensure regulatory compliance for global clinical research. This individual will work in a team-oriented environment and engage in a wide range of activities, focused on policies, processes, staff training and clinical compliance initiatives. The role is also responsible for recognizing, documenting, and assisting in escalating risks relevant to GCP/GXP/GVP activities.
Required Skills
Required Experience
BASIC QUALIFICATIONS:
PREFERRED QUALIFICATIONS:
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
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.
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