Associate Director Clinical Trial Materials
Associate Director Clinical Trial Materials
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Salary Not Disclosed
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Job Description
Please note that this position is based in Princeton NJ or San Diego CA. Acadias hybrid model requires this role to work in our office three days per week on average.
Position Summary:
The Associate Director (AD) Clinical Trial Materials (CTM) plays a pivotal role in the success of clinical development programs across Phase IIV 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.
Primary Responsibilities:
- Review and Interpretation of a clinical protocol or study overview:
o Review and provide feedback during the development of the clinical protocol
o Calculate total demand and translation of total demand into a demand forecast
o Interface with Project Managers to develop clinical supply timelines obtain study overviews and drug requirements and initiate procurement procedures
o 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
o Tracks expired materials and issues orders for retrieval or disposal
o Be proficient with current inventory and tracking systems by learning their usage updates and maintenance
o Proposes and implements improvements to assure efficient clinical supply operations
o Investigates and resolves issues regarding inventory shipments and returns
o Responsible for end to end full CTM lifecycle ensures that all clinical trials have timely and an un-interrupted supply of CTM
o 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
Education/Experience/Skills:
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.
Must possess:
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.
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 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
#LI-hybrid #LI-SW1
#LI-SW1
Required Experience:
Director
Employment Type
Full Time
