Senior Director, Clinical Operations - Akebia Therapeutics

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?

Reporting to the VP, Clinical Development, the successful candidate will direct therapeutically focused teams and oversee clinical program(s) including development plan strategy, clinical trial design and execution (Phase 1-4 and post-marketing regulatory studies). Establish consistent clinical research practices and ensure regulatory compliance across assigned project teams. In conjunction with the VP, Clinical Development and with cross-functional project team members, the Sr. Director, Clinical Operations is accountable for successful delivery of all programs. The Sr. Director, Clinical Operations, must have experience managing and providing oversight of clinical programs and be able to effectively manage interactions across functions, third-party providers, and investigators/advisors/thought leaders. The individual will be responsible for management of budgets, timelines and resources for clinical development program(s) and may provide oversight to other staff and functions.

• Provide therapeutically focused support and oversight to staff for development and optimization of global clinical strategy and processes, including effective delegation to direct reports to meet program goals
• Support VP Clinical Development with the implementation of initiatives, serve as liaison/change management champion for Clinical Operations
• Proactively work with clinical teams to develop and ensure effective implementation of compound development and study execution plans.
• Facilitate problem-solving and conflict resolution with internal and external stakeholders to prospectively reduce issues / remove roadblocks and keep teams on track with key deliverables across the compound(s).
• Responsible and accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage, and resolve issues that arise during study and program conduct; manage escalation of study and program-related issues.
• Oversee the development of budgets and timelines for Program(s). Work with study team(s) to ensure accurate forecasting, tracking, and timely review of study budgets. Facilitate timely escalation of variances within established processes
• Translates corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third-party vendors and drives optimal delivery.
• Oversee and ensure the development of accurate program and study-level plans. Actively contribute to the project team(s), supporting the strategic planning and execution of clinical development plans, including all governance processes, external consultants, and partnering activities.
• Support the development, and expansion, of the clinical operations team(s) to ensure successfully implementation and delivery of clinical programs.
• Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones.

Basic Qualifications:

• BS Degree in science or a health-related field is required.
• Must have at least 15 years of direct clinical trial management experience.
• Must have multi-trial, Phase 2/3, global experience in a leadership role.

Preferred Skills:

• Must be able to travel up to 25%
• Detail-oriented and good problem-solving ability.
• Ability to work on teams and with multiple projects and work well under general direction.
• Working knowledge of medical terminology
• Excellent computer skills.
• Proficient knowledge of GCP, ICH, and FDA regulations.
• Ability to provide appropriate leadership to clinical sites and team members.
• Independently motivated.

Compensation:

Targeted Base: $241,931 - $298,856*

*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

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.

Required Skills


Required Experience