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?
Job Summary:
Reporting to the Sr. Director, Clinical Operations, the successful candidate will provide operational leadership and expertise in the implementation and execution of clinical study programs, ensuring the timely completion of deliverables through the development and management of the project timelines and budgets. In conjunction with the Senior Director, Clinical Operations and with cross-functional project team members, the Director, Clinical Operations is accountable for successful operational delivery of all studies within the Clinical Development Plan (CDP) through the program lifecycle (from planning, execution, data delivery and inspection planning and support activities) The Director of Clinical Operations, must have experience managing and providing oversight of clinical studies outsourced to third party vendors (CROs, central labs, IWRS, clinical supplies etc.) but also experience managing studies in-house without a full-service CRO. The individual should be able to effectively manage interactions between functional groups such as monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA. The individual will also be responsible for building and maintaining relationships with clinical investigators/advisors/thought leaders, sites and other external parties as needed. Additionally, the individual collaborates with key stakeholders internally and externally to understand the global therapeutic landscape and leverages this knowledge for the benefit of the program (eg establishing geographic recruitment strategies).
Essential Functions and Duties:
Required Qualifications
Desired Qualifications
Compensation
Targeted Base: $202,940-$250,690
*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company’s total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
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 characteristics protected by applicable law.
Required Skills
Required Experience