Associate Director Clinical Operations
Acadia Pharmaceuticals
8 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
This role supports Clinical Operations’ management objectives to perform high-quality clinical trials delivered on agreed timelines and budget. Manages clinical operations processes including project planning, budget, resource management, and CRO management. Serves as a key contact/resource for Clinical Study Managers, CRAs, and Clinical Trial Assistants. Ensures studies are carried out according to GCP and company SOPs; assists with creation/implementation of policies and works cross-functionally to ensure required inputs and updates.
Primary Responsibilities
- Manage clinical operations teams; represent Clinical Operations on multi-function projects (internally/externally). Work with investigators and CSPs to develop, execute, and deliver clinical studies.
- Ensure quality study enrollment within budget and timelines.
- Participate in design/review of clinical protocols, case report forms, tools/tracking systems, and IXRS systems.
- Develop/manage vendor and site staff relationships; maintain documentation; perform risk analyses; may participate in due diligence/audit reviews.
- Communicate project status/issues to management and team.
- Prepare/oversee study documents (Project Plan, Risk Management Plan, Monitoring Plan, TMF, etc.).
- Manage/review CRO work to ensure scope and budget adherence.
- Liaise with functional groups to meet timelines, budgets, and objectives; coordinate with Clinical GCP group to meet quality metrics.
- Oversee clinical study budgets.
- Provide day-to-day direction to Study Managers and Clinical Trial Assistants.
- Ensure compliance with GCP, GDP, and regulatory guidelines.
- Recommend/implement innovative process ideas.
- Other responsibilities as assigned.
Education/Experience/Skills
- Bachelor’s degree in life sciences (or related field).
- Targeting 8 years progressively responsible pharmaceutical experience focused on clinical trials and late phase development.
- Leadership experience and CNS therapeutic experience preferred; equivalent education/experience considered.
Key Skills (Required/Preferred)
- Knowledge of GCP and clinical trials regulations/guidelines.
- Experience developing protocols, SOPs, Clinical Study Reports, and NDA-supporting documents.
- Demonstrated ability to develop/implement/manage clinical trials.
- Clinical trial strategies/methods/processes; knowledge of clinical trial design.
- Technical, administrative, and project management capabilities.
- Strong interpersonal, organizational, workload planning, and verbal/written communication.
- Proficient in Microsoft Word/Excel.
- Ability to negotiate/influence and align resources to functional goals.
- Ability to manage multiple priorities; work cross-functionally in fast-paced environment.
- Willing and able to travel domestically and internationally.
This role supports Clinical Operations’ management objectives to perform high-quality clinical trials delivered on agreed timelines and budget. Manages clinical operations processes including project planning, budget, resource management, and CRO management. Serves as a key contact/resource for Clinical Study Managers, CRAs, and Clinical Trial Assistants. Ensures studies are carried out according to GCP and company SOPs; assists with creation/implementation of policies and works cross-functionally to ensure required inputs and updates.
Primary Responsibilities
- Manage clinical operations teams; represent Clinical Operations on multi-function projects (internally/externally). Work with investigators and CSPs to develop, execute, and deliver clinical studies.
- Ensure quality study enrollment within budget and timelines.
- Participate in design/review of clinical protocols, case report forms, tools/tracking systems, and IXRS systems.
- Develop/manage vendor and site staff relationships; maintain documentation; perform risk analyses; may participate in due diligence/audit reviews.
- Communicate project status/issues to management and team.
- Prepare/oversee study documents (Project Plan, Risk Management Plan, Monitoring Plan, TMF, etc.).
- Manage/review CRO work to ensure scope and budget adherence.
- Liaise with functional groups to meet timelines, budgets, and objectives; coordinate with Clinical GCP group to meet quality metrics.
- Oversee clinical study budgets.
- Provide day-to-day direction to Study Managers and Clinical Trial Assistants.
- Ensure compliance with GCP, GDP, and regulatory guidelines.
- Recommend/implement innovative process ideas.
- Other responsibilities as assigned.
Education/Experience/Skills
- Bachelor’s degree in life sciences (or related field).
- Targeting 8 years progressively responsible pharmaceutical experience focused on clinical trials and late phase development.
- Leadership experience and CNS therapeutic experience preferred; equivalent education/experience considered.
Key Skills (Required/Preferred)
- Knowledge of GCP and clinical trials regulations/guidelines.
- Experience developing protocols, SOPs, Clinical Study Reports, and NDA-supporting documents.
- Demonstrated ability to develop/implement/manage clinical trials.
- Clinical trial strategies/methods/processes; knowledge of clinical trial design.
- Technical, administrative, and project management capabilities.
- Strong interpersonal, organizational, workload planning, and verbal/written communication.
- Proficient in Microsoft Word/Excel.
- Ability to negotiate/influence and align resources to functional goals.
- Ability to manage multiple priorities; work cross-functionally in fast-paced environment.
- Willing and able to travel domestically and internationally.