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.

Director of Clinical Trial Materials supports the Sr. Director Clinical Trial Material (CTM) in planning and execution activities for Phase 1-IV and IIS trials. This role defines short- and long-term goals for the CTM team, demand forecasting and budget management, sets production schedules, reviews protocols, ensures label development, and works cross-functionally to align with applicable regulations. It establishes packaging and distribution strategies, tracks and reconciles drug supplies and product re-test dates, and interfaces with internal departments as well as CROs and CMOs to coordinate execution.

It implements and ensures group compliance with global regulations and procedures for production and distribution of investigational products. It also mentors junior CTM team members as required.

• Review and interpretation of a clinical protocol or study overview, including providing feedback during protocol development and translating demand into a forecast.
• Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
• Regularly review and update inventories and supply plans against clinical forecasts, including lot numbers, status, kit genealogy, and expiration date extensions.
• Track expired materials and issue orders for retrieval or disposal. Maintain proficiency with current inventory and tracking systems.
• Challenge current processes and provide innovative solutions to complex issues; evaluate opportunities for improvement.
• Investigate and resolve issues regarding inventory, shipments and returns. Ensure end-to-end CTM lifecycle with timely, uninterrupted supply for all trials.
• Provide and support budgets for existing and planned projects.
• Support CTM activities with CTM-related vendors and internal teams, including Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites as necessary.
• Develop and maintain CTM documentation to support company policies, procedures, and regulatory guidelines.
• Collaborate with Clinical, Regulatory and Quality teams on label text, translations, and label proofs; build confidence with vendors.
• Prepare and review contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness; reconcile and approve invoices.
• Prepare reports ensuring accuracy and completeness of clinical supplies information; maintain departmental reports and SOPs as assigned.

• Minimum Bachelor of Science degree in Health Science (Master’s preferred); equivalent combination with at least 10+ years of pharmaceutical development experience focused on clinical trial materials.
• Well-versed in GMP, GCP, GDP and related regulatory requirements for investigational products (GxP).
• Proven project management skills and ability to lead and train staff to support team effectiveness.
• Ability to manage multiple projects concurrently; strong understanding of GMP environments and regulatory guidance (e.g., ICH, 21 CFR Part 11).
• Experience with IRT system build-up and user testing; strong negotiating skills with customers and suppliers.
• Hands-on training and experience in clinical trial methodology and Good Clinical Practice.
• Excellent organizational, documentation and written/verbal communication skills; ability to convey complex knowledge clearly; team-oriented approach.