Head of Clinical Operations ( On site role)

Oversight of the execution of all clinical trials

Ensures all trials are conducted in accordance with applicable SOPs, ICH, GCP and other applicable regulations.

Responsibility for meeting timelines and the execution of clinical studies making sure deliverables, milestones, and budget parameters are met.

Manages resources and external vendors efficiently

Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment is required.

Overall budget forecasting and management

Responsible for overall budget forecasting and management.

Maintains and provides relevant and accurate information for monthly study reports

• Enrollment curves
• Timelines
• Analysis of the study status
• Identification of potential risks

Clinical Trial material (CTM) Management, budget, and finances, change orders, contracts

Provides Clinical Operations expertise in cross-functional meetings and works closely with cross functional members to ensure the quality and in accordance with Precigen SOPs and global regulatory guidelines.

Education and Experience

• PhD, MD or Bachelors in medical or life science, regulatory science, or related field.
• Strong understanding of global regulatory guidelines and processes.
• Minimum of ten (10)+ years progressive experience in pharma/biopharma clinical operations.
• Experience with biologics/gene therapy is preferred.

Desired Key Competencies

• Ability to understand and execute on the company’s mission and values.
• Exceptional organization skills with strong attention to detail.
• Strong personal leadership and self-direction.
• Clear communication in both oral and written form.
• Demonstrated ability to work with and coordinate demands from multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Advanced skills in Microsoft Word, Adobe Acrobat Professional®, and clinical trial management systems (CTMS).