Associate Director Clinical Operations
Acadia Pharmaceuticals
10 days 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.