Associate Director, Clinical Supply Materials

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

 

Please note that this position is based in Princeton, NJ or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary:

The Associate Director (AD), Clinical Trial Materials (CTM) plays a pivotal role in the success of clinical development programs across Phase I–IV and investigator-initiated studies (IIS). Reporting to the Sr. Director of Clinical Trial Materials, this strategic and hands-on leader is responsible for the end-to-end management of clinical supplies — from demand forecasting and production scheduling to labeling, packaging, distribution, and inventory reconciliation. The AD, CTM works cross-functionally with Clinical Operations, Regulatory, Quality, Data Management, external CROs and CMOs to ensure uninterrupted clinical trial supply while maintaining strict compliance with GMP, GCP, GDP, and all global regulatory requirements.

The ideal candidate is a seasoned pharmaceutical development professional with proven expertise in clinical supply chain operations, project management, and regulatory compliance. They will mentor junior team members, drive operational excellence, champion process improvements, and ensure that supplies are delivered on time, within budget, and to the highest quality standards. This position demands a solutions-oriented mindset, strong leadership skills, and the ability to operate independently in a fast-paced, dynamic environment.

Primary Responsibilities:

•  Review and Interpretation of a clinical protocol or study overview: 
  o    Review and provide feedback during the development of the clinical protocol
  o    Calculate total demand and translation of total demand into a demand forecast
  o    Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures
  o    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
  o    Tracks expired materials and issues orders for retrieval or disposal
  o    Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance
  o    Proposes and implements improvements to assure efficient clinical supply operations
  o    Investigates and resolves issues regarding inventory, shipments and returns
  o    Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM
  o    Provides and supports budgets for existing and newly planned Projects
• Coordinates 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
• 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

Education/Experience/Skills: