Senior Manager, Clinical Supply Specialist

Acadia Pharmaceuticals Inc.•San Diego, CA

8d•Hybrid

About The Position

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. In support of clinical development programs, the Senior Manager of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label 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) as necessary to coordinate the execution of these activities. Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required.

Requirements

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 4-6 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
Ability to handle multiple projects simultaneously
Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
Good understanding of IRT system build-up and user testing
Good negotiating skills with customers and suppliers
Hands on training and experience in clinical trial methodology and Good Clinical Practice
Good 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

Responsibilities

Review and Interpretation of a clinical protocol or study overview:
Review and provide feedback during the development of the clinical protocol.
Calculate 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.
Periodically reviews and updates inventories 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.
Proposes and implements improvements to assure efficient clinical supply operations.
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.
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

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