Associate Director, Clinical Project Management

Clinical --> Clinical Operations

This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.

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:

The Clinical Project Manager is responsible for orchestrating clinical operational activities in support of one or more clinical studies. The company is focused on indications related to anemia, oncology, and vascular development. Each indication will be developed in clinical studies performed on a global scale in coordination with international Clinical Research Organizations. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key Responsibilities:

* 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 assigned clinical programs and translates 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 ensures 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 manages 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.

* Collaborate with the monitoring oversight manager to support site management and monitoring oversight activities in accordance with ICH/GCP standards

* Support continuous process improvement for the clinical operations team including updating procedures, creating templates, and supporting system/ tool updates and implementations where needed.

* May manage other junior members of the clinical operations team (i.e. clinical project managers or CTAs) assigned to the program.

Basic Qualifications:

* BS Degree in science or a health-related field is required.

* 7+ years relevant clinical development experience including 1-2 years at a sponsor company

* 5+ years in a clinical trial management role.

* Experience running trials in-house with little to no outsourcing to clinical CROs

* Experience managing multiple Site Management Organizations as part of a trial

* Must be able to travel up to 25%.

Preferred Qualifications:

* Detail oriented and good problem-solving ability.

* Ability to work on teams and with multiple projects and works well under general direction.

* Line management experience preferred.

* Rare disease experience preferred.

* 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: 160,500-198,264.00*

*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 factors prohibited by law.