Acadia Pharmaceuticals is seeking an Associate Director Clinical Operations to support Clinical Operations' management objectives, managing clinical operations processes, and ensuring clinical studies are carried out and delivered according to GCP and company SOPs.
Requirements
- Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally.
- Ensures quality delivery of study enrollment within agreed budgets and timelines.
- Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.
- Develops and manages relationships with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and audit reviews.
- Effectively communicates project status and issues to management and the team.
- Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.
- Manages and reviews the work of Contract Research Organization (CRO) to ensure that tasks are performed to scope and budget.
- Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.
- Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout a trial.
- Oversees clinical study budgets.
- Provides day-to-day direction to Study Managers and Clinical Trial Assistants to carry out their work.
- Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.
- Recommends and implements innovative process ideas to positively impact clinical trials management.
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
