Associate Director, Clinical Operations
Artiva Biotherapeutics
5 hours ago
Remote friendly (San Diego, CA)
United States
Operations
Job Summary:
The Associate Director, Clinical Operations will manage clinical trials as part of the clinical operations team and oversee daily operations of clinical programs through vendors. May lead a small team and provide vision, leadership, and mentoring.
Duties/Responsibilities:
- Manage complex Phase 1–4 clinical trials.
- Oversee CROs within a quality framework supporting early and confirmatory trials.
- Provide direction for CRO/vendor selection and management.
- Support regulatory start-up process planning.
- Build, manage, and maintain high-performing clinical teams.
- Contribute to strategic planning, including enrollment modeling for portfolio optimization and spend/timeline analysis.
- Provide technical expertise for clinical documents and trial conduct (protocols, monitoring plans, clinical trial reports, investigator brochures, etc.).
- Coordinate cross-functionally with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management, and Regulatory.
- Manage clinical research activity of Clinical Trial Managers and other staff.
- Prepare clinical research budgets and timelines; manage budgets, spend analysis, and accuracy with finance.
- Develop action plans to address issues with investigational sites, CRAs, and CROs.
- Improve SOPs with departmental leadership and Quality.
- Lead RFP preparation, bid solicitation, proposal evaluation, and vendor selection rationale.
- Manage vendor agreements for outsourced activities, including adherence to scope, budgets, plans, and timelines; ensure change orders meet clinical operations specifications.
- Drive feasibility and site selection.
- Drive enrollment efforts to deliver the program.
Requirements:
- Bachelor’s degree in life sciences (advanced degree strongly preferred).
- Strongly preferred: Cell Therapy, Autoimmune, or Rare Disease experience.
- 10+ years relevant industry experience, including CRO/vendor management, leading clinical operations from early through late-stage trials.
- Expertise in drug development, operations, and strategic planning for clinical trial operations.
- Experience managing and mentoring in a matrix environment.
- Knowledge of international clinical pharmaceutical standards, ICH/GCP, and regulatory compliance.
- Extensive experience managing CROs, central laboratories, and other study vendors.
- Working knowledge of data management/review/analysis and drug safety/pharmacovigilance.
- Ability to solve complex problems; prioritize and handle multiple tasks.
- Effective leadership and communication skills.
Benefits:
- Medical, Dental, Vision; Group Life Insurance; LTD; 401(k); EAP; FSA; Paid Time Off; company-paid holidays.
Travel:
- Up to 25% (may include international travel).
The Associate Director, Clinical Operations will manage clinical trials as part of the clinical operations team and oversee daily operations of clinical programs through vendors. May lead a small team and provide vision, leadership, and mentoring.
Duties/Responsibilities:
- Manage complex Phase 1–4 clinical trials.
- Oversee CROs within a quality framework supporting early and confirmatory trials.
- Provide direction for CRO/vendor selection and management.
- Support regulatory start-up process planning.
- Build, manage, and maintain high-performing clinical teams.
- Contribute to strategic planning, including enrollment modeling for portfolio optimization and spend/timeline analysis.
- Provide technical expertise for clinical documents and trial conduct (protocols, monitoring plans, clinical trial reports, investigator brochures, etc.).
- Coordinate cross-functionally with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management, and Regulatory.
- Manage clinical research activity of Clinical Trial Managers and other staff.
- Prepare clinical research budgets and timelines; manage budgets, spend analysis, and accuracy with finance.
- Develop action plans to address issues with investigational sites, CRAs, and CROs.
- Improve SOPs with departmental leadership and Quality.
- Lead RFP preparation, bid solicitation, proposal evaluation, and vendor selection rationale.
- Manage vendor agreements for outsourced activities, including adherence to scope, budgets, plans, and timelines; ensure change orders meet clinical operations specifications.
- Drive feasibility and site selection.
- Drive enrollment efforts to deliver the program.
Requirements:
- Bachelor’s degree in life sciences (advanced degree strongly preferred).
- Strongly preferred: Cell Therapy, Autoimmune, or Rare Disease experience.
- 10+ years relevant industry experience, including CRO/vendor management, leading clinical operations from early through late-stage trials.
- Expertise in drug development, operations, and strategic planning for clinical trial operations.
- Experience managing and mentoring in a matrix environment.
- Knowledge of international clinical pharmaceutical standards, ICH/GCP, and regulatory compliance.
- Extensive experience managing CROs, central laboratories, and other study vendors.
- Working knowledge of data management/review/analysis and drug safety/pharmacovigilance.
- Ability to solve complex problems; prioritize and handle multiple tasks.
- Effective leadership and communication skills.
Benefits:
- Medical, Dental, Vision; Group Life Insurance; LTD; 401(k); EAP; FSA; Paid Time Off; company-paid holidays.
Travel:
- Up to 25% (may include international travel).