Head of Clinical Operations ( On site role)

Role Summary

Precigen is seeking a highly motivated and skilled Head of Clinical Operations (level determined by candidate experience), to drive our clinical trial programs to develop next generation gene and cell therapies focused in immuno-oncology, autoimmune disorders, and infectious diseases. Reporting to the Head of Clinical Operations, this role is responsible for driving organizational strategy and overall execution of clinical program(s) to align with corporate objectives, collaborating with executive leadership and external stakeholders to drive the success of our clinical programs. The position will lead a high-performing Clinical Operations team to ensure work quality, timeliness and adherence to budget. The candidate will have a strong knowledge of global regulatory guidelines, strong organization and time management skills, and demonstrate focus to output/deliverables.

Responsibilities

• 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. Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment is required.
• Manages resources and external vendors efficiently
• Responsible for overall budget forecasting and management
• Maintains and provides relevant and accurate information for monthly study reports (including enrollment curves, timelines, analysis of the study status and identification of potential risks) Clinical Trial material (CTM) Management, budget, and finances, change orders, contracts.
• Provide 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

Qualifications

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

Skills

• 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).

Education

• PhD, MD or Bachelor's in medical or life science, regulatory science, or related field.