Acadia Pharmaceuticals Inc.
Director, Clinical Trial Materials
Acadia Pharmaceuticals Inc., San Diego, California, United States, 92189
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.
Position Summary 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.
Primary Responsibilities
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.
Education/Experience/Skills
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.
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 an office environment and while working remotely. The employee must occasionally lift up to twenty pounds and may travel overnight or work after hours as required by travel schedules or business needs.
#LI-SW1 #LI-HYBRID
In addition to a competitive base salary, this position is eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Salary Range: $177,000 — $221,700 USD.
What we offer US-based Employees
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 24 and January 1
10 days of paid sick time
Paid parental leave and tuition assistance
EEO Statement (US-based Employees):
Acadia is committed to building a diverse, equitable, inclusive, and innovative company and strongly encourages applications from candidates of diverse backgrounds. Acadia provides equal employment opportunities to all employees and applicants without regard to protected characteristics or other legally protected status.
As an equal opportunity employer, Acadia supports reasonable accommodations for applicants with disabilities throughout the hiring process. For accommodation requests, please contact talentacquisition@acadia-pharm.com or 858-261-2923.
California Applicants: Additional Information for California Residents can be found in our Privacy Policy. Canadian Applicants: Additional Information for Canadian Residents can be found in our Privacy Policy. Applicants in the EEA/UK/Serbia: Please see Additional Information in our Privacy Policy.
Notice to Search Firms/Recruiters: Acadia does not accept resumes from recruiters without an executed search agreement in place. Resumes sent without an agreement will not obligate Acadia in any way.
#J-18808-Ljbffr
Position Summary 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.
Primary Responsibilities
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.
Education/Experience/Skills
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.
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 an office environment and while working remotely. The employee must occasionally lift up to twenty pounds and may travel overnight or work after hours as required by travel schedules or business needs.
#LI-SW1 #LI-HYBRID
In addition to a competitive base salary, this position is eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Salary Range: $177,000 — $221,700 USD.
What we offer US-based Employees
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 24 and January 1
10 days of paid sick time
Paid parental leave and tuition assistance
EEO Statement (US-based Employees):
Acadia is committed to building a diverse, equitable, inclusive, and innovative company and strongly encourages applications from candidates of diverse backgrounds. Acadia provides equal employment opportunities to all employees and applicants without regard to protected characteristics or other legally protected status.
As an equal opportunity employer, Acadia supports reasonable accommodations for applicants with disabilities throughout the hiring process. For accommodation requests, please contact talentacquisition@acadia-pharm.com or 858-261-2923.
California Applicants: Additional Information for California Residents can be found in our Privacy Policy. Canadian Applicants: Additional Information for Canadian Residents can be found in our Privacy Policy. Applicants in the EEA/UK/Serbia: Please see Additional Information in our Privacy Policy.
Notice to Search Firms/Recruiters: Acadia does not accept resumes from recruiters without an executed search agreement in place. Resumes sent without an agreement will not obligate Acadia in any way.
#J-18808-Ljbffr