Acadia Pharmaceuticals Inc.
Director, Clinical Trial Materials
Acadia Pharmaceuticals Inc., San Diego, California, United States, 92189
Director, Clinical Trial Materials – Acadia Pharmaceuticals Inc.
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 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 role defines short and long‑term goals for the team, oversees demand forecasting and budget management, sets production schedules, reviews protocols, and ensures label development. The Director works cross‑functionally to align compliance with applicable regulations, establishes optimal packaging and distribution strategies, and tracks and reconciles drug supplies and monitors product re‑test dates. Interface with internal departments and contract research organizations (CROs) and contract manufacturing organizations (CMOs) as necessary to coordinate the execution of these activities. Implements and ensures group compliance with global applicable regulations and procedures for the production and distribution of investigation product. Mentors junior colleagues in the CTM team as required.
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 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 review and update 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.
Track expired materials and issue orders for retrieval or disposal.
Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
Challenge current processes, practices and strategies.
Provide innovative solutions to complex issues and consistently evaluate opportunities for improvement.
Investigate and resolve issues regarding inventory, shipments and returns.
Responsible for end‑to‑end, full CTM lifecycle, ensuring that all clinical trials have a timely and uninterrupted supply of CTM.
Provide and support budgets for existing and newly planned projects.
Support 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.
Develop and maintain CTM documentation necessary to support company policies, procedures and all regulatory guidelines.
Work with clinical, regulatory and quality teams in preparing label text, obtaining translations and approval of label proofs.
Work collaboratively with vendors to optimize relationships and build confidence.
Prepare and review applicable 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 other projects as assigned.
Education, Experience and Skills
Minimum 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 10 + years of experience in pharmaceutical development focused on clinical trial materials.
Well versed in GxPs (GMP, GCP, GDP) and other regulatory requirements as they pertain to investigational products.
Proven project management skills.
Develops team building and training of staff to support team skills and enhance operational effectiveness.
Ability to handle multiple projects/staff simultaneously.
Excellent understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH, 21 CFR Part 11).
Excellent understanding and working knowledge of IRT system build‑up and user testing.
Experience in negotiating skills with customers and suppliers.
Hands‑on training and experience in clinical trial methodology and Good Clinical Practice.
Excellent organizational and documentation skills.
Demonstrated track record of ability to self‑direct and resolve issues with vendors, CRO staff and internal teams.
Excellent written and verbal communication skills.
Skilled at clearly conveying in‑depth knowledge to all levels within, and outside of, the organization.
Skilled at creating a cooperative team environment.
Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
Physical Requirements This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also 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. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
Salary Range $177,000—$221,700 USD
Benefits – 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 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
EEO Statement (US-based Employees) Acadia is 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.
Acadia provides equal employment opportunities to all employees and employment applicants without regard to race, color, religion, sexual orientation, gender identity, gender expression, genetic information, veteran status, and any other protected class under federal, state, or local law. Employees with a disability or disabled veterans may request reasonable accommodations. Contact talentacquisition@acadia-pharm.com for accommodation requests.
Seniority Level Director
Employment Type Full‑time
Job Function Management and Manufacturing
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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 role defines short and long‑term goals for the team, oversees demand forecasting and budget management, sets production schedules, reviews protocols, and ensures label development. The Director works cross‑functionally to align compliance with applicable regulations, establishes optimal packaging and distribution strategies, and tracks and reconciles drug supplies and monitors product re‑test dates. Interface with internal departments and contract research organizations (CROs) and contract manufacturing organizations (CMOs) as necessary to coordinate the execution of these activities. Implements and ensures group compliance with global applicable regulations and procedures for the production and distribution of investigation product. Mentors junior colleagues in the CTM team as required.
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 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 review and update 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.
Track expired materials and issue orders for retrieval or disposal.
Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
Challenge current processes, practices and strategies.
Provide innovative solutions to complex issues and consistently evaluate opportunities for improvement.
Investigate and resolve issues regarding inventory, shipments and returns.
Responsible for end‑to‑end, full CTM lifecycle, ensuring that all clinical trials have a timely and uninterrupted supply of CTM.
Provide and support budgets for existing and newly planned projects.
Support 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.
Develop and maintain CTM documentation necessary to support company policies, procedures and all regulatory guidelines.
Work with clinical, regulatory and quality teams in preparing label text, obtaining translations and approval of label proofs.
Work collaboratively with vendors to optimize relationships and build confidence.
Prepare and review applicable 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 other projects as assigned.
Education, Experience and Skills
Minimum 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 10 + years of experience in pharmaceutical development focused on clinical trial materials.
Well versed in GxPs (GMP, GCP, GDP) and other regulatory requirements as they pertain to investigational products.
Proven project management skills.
Develops team building and training of staff to support team skills and enhance operational effectiveness.
Ability to handle multiple projects/staff simultaneously.
Excellent understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH, 21 CFR Part 11).
Excellent understanding and working knowledge of IRT system build‑up and user testing.
Experience in negotiating skills with customers and suppliers.
Hands‑on training and experience in clinical trial methodology and Good Clinical Practice.
Excellent organizational and documentation skills.
Demonstrated track record of ability to self‑direct and resolve issues with vendors, CRO staff and internal teams.
Excellent written and verbal communication skills.
Skilled at clearly conveying in‑depth knowledge to all levels within, and outside of, the organization.
Skilled at creating a cooperative team environment.
Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
Physical Requirements This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also 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. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
Salary Range $177,000—$221,700 USD
Benefits – 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 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
EEO Statement (US-based Employees) Acadia is 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.
Acadia provides equal employment opportunities to all employees and employment applicants without regard to race, color, religion, sexual orientation, gender identity, gender expression, genetic information, veteran status, and any other protected class under federal, state, or local law. Employees with a disability or disabled veterans may request reasonable accommodations. Contact talentacquisition@acadia-pharm.com for accommodation requests.
Seniority Level Director
Employment Type Full‑time
Job Function Management and Manufacturing
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