Associate Director, Clinical Project Management

Akebia Therapeutics•Cambridge, MA

5d•Hybrid

About The Position

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).

Requirements

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%.
Detail oriented and good problem-solving ability.
Ability to work on teams and with multiple projects and works well under general direction.
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.

Nice To Haves

Line management experience preferred.
Rare disease experience preferred.
Working knowledge of medical terminology.

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.