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 Senior Director, Clinical Operations is responsible for managing all aspects of clinical development programs, Reporting to the VP, Clinical Operations. The successful candidate will provide operational leadership, guidance 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 VP, Clinical Operations and with cross-functional project team members, the Senior 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 Senior Director of Clinical Operations, must have experience managing and providing oversight of  clinical studies outsourced to third party vendors (CROs, central labs, IRT, clinical supplies etc.) and be able to effectively manage interactions between functional groups such as monitoring, data management, biostatistics, medical writing, clinical research, clinical pharmacology, safety, regulatory affairs and QA. The individual will also be responsible for building and maintaining relationships with clinical investigators/advisors/thought leaders. 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).

Required Skills

• Responsible for multiple direct reports; Director level and below.

• Leverages resources, expertise, and knowledge across projects, including specific operational strategies.

• Leads clinical operations strategic planning activities for clinical programs and translate strategic decisions into actionable operational plans.

• Leads the budget negotiation process and finalization with key clinical vendors. This role will be accountable to Senior Management for ensuring studies stay within their approved clinical project budgets.

• Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones

• Develops key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools etc.

• Participates in developing the feasibility and site selection strategy.

• Works with various in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing and study drug supply plans, cross-functional communication/interaction plan and monitoring.

• Develops and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.

• Collaborates to generate high quality clinical study reports, investigator brochures, clinical protocols, and publications.

• Prepares and deliver effective presentations to the Project Team, Senior Management, and external parties.

• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.

• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.

• Perform other duties as requested by the senior management.

Required Experience

Basic Qualifications:

• BS Degree
• 10+ years of experience in direct project management of studies within clinical research operations.
• Experience managing direct reports
• Experience with agency submissions and inspections.
• Experience leading cross-functional teams for a minimum of 5 years.
• Experience in phase 1-4 clinical studies.
• Global experience.

Preferred Qualifications:

• BS Degree in life science 
• Understands and ensures adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations, with strong understanding of and experience in agency inspection readiness.
• Working knowledge of medical terminology.
• Ability to provide appropriate leadership to clinical sites and team members as appropriate
• Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.
• Demonstrated project management expertise, including the leadership and development of cross functional teams.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.

Additional Responsibilities

• Must be able to travel up to 25%

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

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.  

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.

#LI-MS1

• Responsible for multiple direct reports; Director level and below.

• Leverages resources, expertise, and knowledge across projects, including specific operational strategies.

• Leads clinical operations strategic planning activities for clinical programs and translate strategic decisions into actionable operational plans.

• Leads the budget negotiation process and finalization with key clinical vendors. This role will be accountable to Senior Management for ensuring studies stay within their approved clinical project budgets.

• Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources, and milestones

• Develops key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools etc.

• Participates in developing the feasibility and site selection strategy.

• Works with various in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing and study drug supply plans, cross-functional communication/interaction plan and monitoring.

• Develops and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.

• Collaborates to generate high quality clinical study reports, investigator brochures, clinical protocols, and publications.

• Prepares and deliver effective presentations to the Project Team, Senior Management, and external parties.

• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.

• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.

• Perform other duties as requested by the senior management.