Acadia Pharmaceuticals Inc. · 3 months ago
Director, Clinical Trial Materials
Princeton, New Jersey, United States
Full-time
Onsite
Director/Executive
$177K/yr - $222K/yr
10+ years expAcadia Pharmaceuticals is dedicated to innovative treatments for underserved neurological and rare disease communities. The Director of Clinical Trial Materials will support clinical development programs by managing the lifecycle of clinical trial materials, ensuring compliance with regulations, and coordinating with various internal and external stakeholders.
BiotechnologyHealth CarePharmaceutical
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
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
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
Qualification
Required
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
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
Company
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals develops and commercializes small molecule drugs for the treatment of central nervous system disorders.
501-1000 employees
H1B Sponsorship
Acadia Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$811.73MKey Investors
National Institute of Neurological Disorders and StrokeOxford Bioscience PartnersNational Institute of Mental Health
2019-09-17Post Ipo Equity· $287.5M
2018-11-30Post Ipo Equity· $316.25M
2013-01-02Post Ipo Equity· $86.39M
Leadership Team
Catherine Adams
Chief Executive Officer
Steve Davis
President and CEO
Recent News
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