Associate Director Clinical Operations
Acadia Pharmaceuticals
4 hours ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Position Summary:
- Support Clinical Operations’ objectives to run high-quality clinical trials on agreed timelines and budgets.
- Manage clinical operations processes including project planning, budget, resource management, and CRO management.
- Serve as a key contact/resource for Clinical Study Managers, CRAs, and Clinical Trial Assistants.
- Ensure studies are delivered according to GCP and company SOPs; assist with policy creation; work cross-functionally to obtain required inputs and updates.
Primary Responsibilities:
- Manage clinical operations teams and represent Clinical Operations on multi-function projects (internal/external); work with investigators and Clinical Service Providers to develop/execute/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 relationships with 3rd-party vendors and clinical site staff; maintain documentation; perform risk analyses; may support due diligence/audits.
- Communicate project status/issues to management and the team.
- Prepare/oversee study documents (Project Plan, Risk Management Plan, Monitoring Plan, TMF, etc.).
- Manage and review CRO work to ensure tasks meet scope and budget.
- Liaise with functional groups to meet timelines/budgets/study objectives; liaise with the 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 process improvements; other duties as assigned.
Qualifications (Education/Experience):
- Bachelor’s degree in life sciences or related field.
- Targeting 8 years’ progressively responsible pharmaceutical experience in clinical trials and late phase development.
- Leadership experience and CNS therapeutic experience preferred; equivalent education/experience may be considered.
Key Skills:
- Knowledge of GCP and clinical trial regulations/guidelines.
- Experience developing clinical protocols, SOPs, Clinical Study Reports, and NDA-supporting documents.
- Demonstrated ability to develop/implement/manage clinical trials.
- Clinical trial strategies/methods/processes and trial design knowledge.
- Technical, administrative, and project management capabilities.
- Strong interpersonal, organizational, workload planning, verbal/written communication skills.
- Proficient with Microsoft Word and Excel.
- Negotiation and ability to influence leaders.
- Ability to align resources to functional goals; manage multiple priorities in a fast-paced environment.
- Willingness to travel domestically and internationally.
Benefits (as stated):
- Discretionary bonus and equity awards eligibility; competitive base salary.
- Medical, dental, vision; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan.
- 15+ vacation days; 13–15 paid holidays; 10 paid sick time; paid parental leave; tuition assistance.
Salary Range (as stated):
- $147,900—$184,900 USD
- Support Clinical Operations’ objectives to run high-quality clinical trials on agreed timelines and budgets.
- Manage clinical operations processes including project planning, budget, resource management, and CRO management.
- Serve as a key contact/resource for Clinical Study Managers, CRAs, and Clinical Trial Assistants.
- Ensure studies are delivered according to GCP and company SOPs; assist with policy creation; work cross-functionally to obtain required inputs and updates.
Primary Responsibilities:
- Manage clinical operations teams and represent Clinical Operations on multi-function projects (internal/external); work with investigators and Clinical Service Providers to develop/execute/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 relationships with 3rd-party vendors and clinical site staff; maintain documentation; perform risk analyses; may support due diligence/audits.
- Communicate project status/issues to management and the team.
- Prepare/oversee study documents (Project Plan, Risk Management Plan, Monitoring Plan, TMF, etc.).
- Manage and review CRO work to ensure tasks meet scope and budget.
- Liaise with functional groups to meet timelines/budgets/study objectives; liaise with the 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 process improvements; other duties as assigned.
Qualifications (Education/Experience):
- Bachelor’s degree in life sciences or related field.
- Targeting 8 years’ progressively responsible pharmaceutical experience in clinical trials and late phase development.
- Leadership experience and CNS therapeutic experience preferred; equivalent education/experience may be considered.
Key Skills:
- Knowledge of GCP and clinical trial regulations/guidelines.
- Experience developing clinical protocols, SOPs, Clinical Study Reports, and NDA-supporting documents.
- Demonstrated ability to develop/implement/manage clinical trials.
- Clinical trial strategies/methods/processes and trial design knowledge.
- Technical, administrative, and project management capabilities.
- Strong interpersonal, organizational, workload planning, verbal/written communication skills.
- Proficient with Microsoft Word and Excel.
- Negotiation and ability to influence leaders.
- Ability to align resources to functional goals; manage multiple priorities in a fast-paced environment.
- Willingness to travel domestically and internationally.
Benefits (as stated):
- Discretionary bonus and equity awards eligibility; competitive base salary.
- Medical, dental, vision; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan.
- 15+ vacation days; 13–15 paid holidays; 10 paid sick time; paid parental leave; tuition assistance.
Salary Range (as stated):
- $147,900—$184,900 USD