Senior Manager Clinical Trial Materials
In support of clinical development programs, the Senior Manager of Clinical Trial Materials is responsible for determining clinical trial material (CTM) requirements and maintains appropriate databases for CTM operations management. Through protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interfaces with other internal departments and contract research organizations (CROs) to coordinate execution of these activities.
- 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
- Establishes and maintains working relationships with pharmacists and study coordinators at participating clinical sites and outside organizations supporting ACADIA sponsored clinical trials
- Communicates re-evaluation dates and other information to all sites when applicable
- Investigates and resolves issues regarding supply orders, shipments, returns, and inventory
- Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
- 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
- Works with Clinical, Regulatory and Quality teams in preparing Label Text; obtain Label Translations, if required
- Coordinates the development, review and approval of Clinical Label Proofs
- Maintains departmental reports and files, updates SOPs and other projects as assigned
- Assists with the forecasting and procurement of clinical supplies and other components
- Interfaces 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
- Bachelor’s degree in pharmacy (BPharm) or related. Master’s degree desirable. Equivalent combination of relevant education and applicable job experience may be considered
- A minimum of 8 years’ progressively responsible experience in pharmaceutical development with a focus on clinical trials materials management
- Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
- 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
- Broad experience working with CROs
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 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
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
EEO Statement: Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
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 from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.