Director, Clinical Operations

Clinical --> Clinical Operations

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:

• Responsible and accountable for one or more clinical studies.
• Leverages resources, expertise and knowledge across projects, including specific operational strategies.
• Oversees and coordinates budgetary activities for assigned programs including study budget creation, forecasting, accruals reporting and invoice approval. Develops and manages timelines.
• Translates corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third-party vendors and drives optimal delivery
• 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 Manages clinical trial implementation with clinical sites, external consultants
• and vendor personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.
• Leads the operational selection of various vendors and the review of proposal requests.
• 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.
• Manages the progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
• 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 delivers effective presentations to the Project Team, Senior Management and external parties.
• Provides oversight of vendors using relevant metrics and tools and monitors progress toward Clinical Operations objectives.
• Oversees contracting and budget-related activities for vendors and clinical trial sites.
• 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.

Required Qualifications

• BS Degree in science or a health-related field is required.
• Minimum 8-10+ years relevant clinical development experience including 1-2 years at a sponsor company
• Previous hands-on experience running trials in-house with little to no outsourcing to clinical CROs
• Experience managing multiple Site Management Organizations as part of a trial
• Experience ensuring clinical operations milestones are met while driving the strategic direction of the Clinical Operations function
• Must be able to travel up to 25%

Desired Qualifications

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

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