Head of Clinical Operations ( On site role)
Precigen
August 18, 2026
Remote friendly (Germantown, MD)
United States
Clinical Research and Development
Head of Clinical Operations
Responsibilities:
- Oversight of execution of all clinical trials.
- Ensure trials are conducted in accordance with applicable SOPs, ICH, GCP, and other regulations.
- Meet study timelines; manage priorities, resources, performance targets, and project initiatives in a global environment to ensure deliverables, milestones, and budget parameters are met.
- Efficiently manage resources and external vendors.
- Own overall budget forecasting and management.
- Maintain and provide accurate monthly study reports (enrollment curves, timelines, study status analysis, and potential risk identification), including CTM management, budget/finances, change orders, and contracts.
- Provide Clinical Operations expertise in cross-functional meetings; ensure quality in line with SOPs and global regulatory guidelines.
Qualifications:
- PhD, MD, or Bachelor’s in medical/life sciences, regulatory science, or related field.
- Strong understanding of global regulatory guidelines and processes.
- Minimum 10+ years progressive experience in pharma/biopharma clinical operations.
- Experience with biologics/gene therapy preferred.
Desired Key Competencies:
- Leadership and self-direction; ethical standards and trustworthiness.
- Exceptional organization with strong attention to detail.
- Clear oral and written communication; coordinate demands from multiple stakeholders.
- Advanced skills: Microsoft Word, Adobe Acrobat Professional, and CTMS.
Responsibilities:
- Oversight of execution of all clinical trials.
- Ensure trials are conducted in accordance with applicable SOPs, ICH, GCP, and other regulations.
- Meet study timelines; manage priorities, resources, performance targets, and project initiatives in a global environment to ensure deliverables, milestones, and budget parameters are met.
- Efficiently manage resources and external vendors.
- Own overall budget forecasting and management.
- Maintain and provide accurate monthly study reports (enrollment curves, timelines, study status analysis, and potential risk identification), including CTM management, budget/finances, change orders, and contracts.
- Provide Clinical Operations expertise in cross-functional meetings; ensure quality in line with SOPs and global regulatory guidelines.
Qualifications:
- PhD, MD, or Bachelor’s in medical/life sciences, regulatory science, or related field.
- Strong understanding of global regulatory guidelines and processes.
- Minimum 10+ years progressive experience in pharma/biopharma clinical operations.
- Experience with biologics/gene therapy preferred.
Desired Key Competencies:
- Leadership and self-direction; ethical standards and trustworthiness.
- Exceptional organization with strong attention to detail.
- Clear oral and written communication; coordinate demands from multiple stakeholders.
- Advanced skills: Microsoft Word, Adobe Acrobat Professional, and CTMS.