Associate Director Clinical Operations

Acadia Pharmaceuticals Inc.•San Diego, CA

7h•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. Please note that this position can be based in Princeton, NJ, OR San Diego, CA, OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary This role is responsible for supporting Clinical Operations’ management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operations processes including project planning, budget, resource management, and contract research organization management. This role serves as a key contact and resource for Clinical Study Managers, CRA’s and Clinical Trial Assistants. Responsible for ensuring that clinical studies are carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-functionally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.

Requirements

Bachelor’s degree in life sciences or related field. Targeting 8 years’ progressively responsible pharmaceutical experience with a focus on clinical trials and late phase development. Leadership experience and CNS therapeutic experience preferred. An equivalent combination of relevant education and applicable job experience may be considered.
Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.
Experience developing clinical protocols, Standard Operation Procedures (SOP), Clinical Study Reports, and other documents to support New Drug Application (NDA).
Demonstrated ability to successfully develop, implement, and manage clinical trials.
Practical experience in clinical trial strategies, methods, and processes; knowledge of clinical trial design.
Demonstrated technical, administrative, and project management capabilities.
Strong interpersonal, organizational, and workload planning skills, along with excellent verbal and written communication skills.
Proficient computer skills, including Microsoft Word and Excel.
Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the department or segments of the organization.
Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.
Must be willing and able to travel both domestically and internationally.

Nice To Haves

Leadership experience and CNS therapeutic experience preferred.

Responsibilities

Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.
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.
Other responsibilities 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