Senior Manager, Clinical Trial Materials

<div class="content-intro"><p></p> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow"><strong data-ogsc="" data-olk-copy-source="MessageBody">About Acadia Pharmaceuticals</strong></span></div> <div data-ogsc="black"> </div> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow">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.</span></div></div><p><strong><u>Position Summary:</u></strong></p> <p>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. </p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Review and Interpretation of a clinical protocol or study overview: <ul> <li>Review and provide feedback during the development of the clinical protocol.</li> <li>Calculate total demand and translation of total demand into a demand forecast.</li> <li>Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.</li> <li>Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.</li> <li>Tracks expired materials and issues orders for retrieval or disposal.</li> <li>Be proficient with current