Associate Director, Clinical Trial Materials

Acadia Pharmaceuticals Inc.•San Diego, CA

3h•Hybrid

About The Position

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.

Requirements

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 8 years’ experience in pharmaceutical development focused on clinical trial materials.
The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products.
Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
Good understanding and working knowledge of IRT system build-up and user testing
Hands on training and experience in clinical trial methodology and Good Clinical Practice
Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
Must be able to travel domestically and/or internationally on occasion if business requires.

Responsibilities

Review and provide feedback during the development of the clinical protocol
Calculate 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
Proposes and implements improvements to assure efficient clinical supply operations
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
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

Benefits

Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance