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 the difference.

Position Summary

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. The director defines short‑ and long‑term goals for the team, manages demand forecasting and budget, sets production schedules, reviews protocols, ensures label development and compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies, and monitors product re‑test dates. The role interfaces with internal departments, CROs and CMOs to coordinate execution, implements compliance with global regulations, and mentors junior team members.

Primary Responsibilities

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 translate it into a demand 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, current status, kit genealogy and expiration dates.
• Track expired materials and issue orders for retrieval or disposal.
• Be proficient with current inventory and tracking systems.
• Challenge current processes, practices and strategies.
• Provide innovative solutions to complex issues and evaluate opportunities for improvement.
• Investigate and resolve issues regarding inventory, shipments and returns.
• Ensure end‑to‑end CTM lifecycle support so that all clinical trials have a timely and uninterrupted supply of CTM.
• Support budgets for existing and newly planned projects.
• Support CTM activities Clinical Supply Packagers, Distributors, Technical Services, Clinical R&D staff, Project Teams, IT / IS, Data Management, CROs and other sites and departments as necessary.
• Develop and maintain CTM documentation needed to support company policies, procedures and regulatory guidelines.
• Work with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs.
• Collaborate with vendors to optimize relationships and build confidence.
• Prepare and review contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness.
• Reconcile and approve invoices.
• Prepare reports to ensure accuracy and completeness of clinical supplies information; maintain departmental reports and files, update SOPs and complete assigned projects.

Qualifications

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and / or move up to twenty pounds. The position requires the ability to travel independently overnight and / or work after hours as required by travel schedules or business needs.

Salary and Benefits

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Salary range : $177,000—$221,700 USD.

Benefits for US‑based employees :

EEO Statement (US‑based Employees)

We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the best candidate for the job. That candidate may come from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here. It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to protected characteristics as defined by federal, state and local law. As an equal‑opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation.

To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858‑261‑2923.

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