Director, Clinical Trial Materials

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.

At Acadia, we’re here to be their difference.

In support of clinical development programs, the Director of Clinical Trial Materials role supports the Sr. Director Clinical Trial Material (CTM) in planning and execution activities, supporting Phase 1-IV and IIS trials. Includes defining short and long term goals for the Team, demand forecasting and budget management, setting production schedules, protocol review, ensures label development and works cross functionally to align compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates.

Interface with internal departments and contract research organizations (CROs) and Contract Manufacturing Organizations (CMOs) as necessary to coordinate the execution of these activities. Implements and ensures group compliance to Global applicable regulations and procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required.

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Evaluate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Regularly reviews and updates inventories and supply plan against Clinical forecasts including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Challenges current processes, practices and strategies
  • Provides innovative solutions to complex issues and consistently evaluates opportunities for improvement.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
  • Provides and supports budgets for existing and newly planned Projects.
• Supports CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Works collaboratively with Vendors to optimize relationships and build confidence.
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information. Maintains departmental reports and files, updates SOPs and other projects as assigned

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 10+ years of experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well…