AKEBIA THERAPEUTICS INC

The Associate Director of Monitoring takes a leadership role in the development, implementation, management, and governance of monitioring oversight activities across Akebia’s clinical programs to ensure quality data is delivered in alignment with the needs of the Clinical Development team. This position has oversight responsbilities for clinical monitoring approaches employed in conduct of clinical trials (e.g., onsite, remote, centralized, etc.) This position will represent Akebia in regulatory inspections with health care regulatory authorities around the world, such as the United States Fo... view job details

Akebia Therapeutics, Inc., is looking for an experienced hands-on Associate Director, Accounting (AD, Accounting) who is an enthusiastic, strong leader with a solid technical accounting background. The AD, Accounting will report to the Director of Finance and will play a critical role in driving processes to ensure a high quality, accurate and efficient monthly and quarterly close that enables the Company to meet its external SEC reporting/filing timelines, all while ensuring the Company’s SOX internal controls are operating effectively, and the Company’s books and records are in compliance wi... view job details

This is an outstanding leadership opportunity to join a fast-paced company with a robust development program. Akebia is seeking a motivated and talented Analytical Development professional to join the CMC Operations department. The successful candidate will lead drug substance and product analytical development from early stages to commercialization. This individual will report to the Director of Analytical Development, supervise Analytical Development scientists, and work with cross-functional teams and external partners to lead analytical chemistry projects. The position will be responsible ... view job details

Reporting to Senior Director, Technical Operations, the Associate Director of Analytical Operations will provide overall leadership to the Analytical Operations group; leading a group of scientists in the oversight of third party GMP, contract testing labs including but not limited to method transfer, method qualification and validation as well as routine GMP testing (in process, lot release and stability testing) of Akebia’s commercial products. The Associate Director will support the portfolio of commercial programs to ensure timely delivery of commercial supplies and will assemble, review a... view job details

The Senior Manager, Document and Training Management is responsible for ensuring that the document management and control program as well as the training program are developed, implemented and effectively administered, in a manner that maximizes efficiency, complies with industry standards, and achieves desired compliance targets.  Lead the development and implementation of training and document management programs across Akebia.  Thoroughly identify training and document management needs, articulate goals for meeting these needs, and identify creative, high impact and sustainable approaches f... view job details

As part of Medical Affairs, the AD, Medical Outcomes Liaison (MOL) provides scientific information to payors, PBMs, large dialysis centers, and other large population-based decision-making organized customer groups (PBDM OCGs) in the US.  The MOL’s primary function is field-focused, through scientific exchange that translates Akebia HEOR and clinical information into relevant scientific value-based discussions for PBDM OCGs.  The MOL supports Akebia’s commitment to engage healthcare professionals, patients, advocacy groups, payors, PBMs and other large PBDM OCGs. The MOL strategically supports... view job details

Akebia Therapeutics, Inc., is looking for an experienced hands-on Associate Director, Payroll who is an enthusiastic, strong leader with a solid payroll background. The Associate Director, Payroll will report to the Director of Finance and will manage the payroll function for Akebia and its fast paced, growing employee base. This role requires a seasoned payroll professional to bring best practice knowledge and experience to payroll processes and systems. A high level of leadership, team management, customer service focus and the ability to execute is a must view job details

The Associate Director Logistics and Planning will lead both the Logistics Team and the Planning Team. The Associate Director will be responsible for inventory planning, reconciliation, accuracy, tracking, reporting, and auditing. Will be the primary liaison with third party logistics providers, freight vendors, customs brokers, and other key supply chain vendors. Responsible for ensuring on-time and in-full delivery for both clinical and commercial products at all product stages. The Associate Director will be a member of cross-functional teams, working closely with Operations Management, Tec... view job details

The Associate Director of Records Information Management (RIM) is responsible for management, control, storage and regulatory compliance of the trial master file (TMF) and supporting documents from set-up through archival.  In addition, the Director will be the Named Archivist for Akebia in compliance with ICH E3.  The individual will develop records maintenance standards including: the system(s) for management and archival, implementation and maintenance for managing clinical trial information and records storage space is available and maintained appropriate to industry standards. This positi... view job details

Akebia is seeking an Associate Director Research QA.  This role is suited to candidates who possess strong leadership skills and strategic thinking. Utilizing expert Good Clinical and Good Laboratory Practices this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization. You will be a part of an expert team supporting global clinical development and post-marketing programs including a special emphasis on pediatric trials view job details