Director, Clinical Trial Materials

Acadia Pharmaceuticals Director Of Clinical Trial Materials

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. Includes defining short and long term goals for the team, demand forecasting and budget management, setting production schedules, protocol review, ensures label development and works cross functionally to align compliance with applicable regulations, establishes optimal packaging & distribution strategies, 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 to Global applicable regulations and procedures for the production and distribution of investigation product. Mentor 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 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.
• Challenges current processes, practices and strategies - provides innovative solutions to complex issues and consistently evaluates opportunities for improvement.
• Investigate and resolve 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.
• Supports 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.
• Works collaboratively with Vendors to optimize relationships and build confidence.
• 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 :

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. 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. 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. Experienced 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 the 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

What We Offer US-Based Employees :

EEO Statement (US-Based Employees) :

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. 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 be one who comes 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 considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or 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. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. 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.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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Notice to Search Firms / Third-Party Recruitment Agencies (Recruiters) : The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. ("Acadia"). Acadia does not accept resumes