Precigen is seeking a highly motivated and skilled Executive Director, Clinical Operations (level determined by candidate experience), to drive our clinical trial program efforts in cellular and gene therapies in immuno-oncology, autoimmunity and infectious disease indications. Reporting to the Head of Clinical Operations, this role is responsible for driving organizational strategy and overall execution of assigned clinical program(s) which includes budget, timelines, quality, resource management and providing operational strategies in support of achieving clinical program objectives. The candidate will provide leadership to the Clinical Operation team(s) including in-house team members, Contract Research Organizations (CROs), vendors and other suppliers to ensure work quality, timeliness and adherence to budget. The Senior Director/Executive Director will represent the company at clinical sites and external project meetings as required.

The position will have a strong knowledge of ICH guidelines and FDA guidances. Strong organization and time management skills, an ability to work on multiple projects simultaneously, and excellent attention to detail are required.

We are open to this role being hybrid, with onsite time in our Germantown office.

Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons.

DUTIES AND RESPONSIBILITIES:

• Ensures all clinical programs are conducted in accordance with applicable SOPs, ICH, GCP and other applicable regulations.
• Establish study milestones and ensure accurate tracking and reporting of study metrics.
• Responsible for meeting timelines and the execution of clinical studies making sure deliverables, milestones, and budget parameters are met.
• Leads the selection and management of CROs and other external vendors and develops and maintains strong partnerships.
• Proactively identifies project risks and development of remediation measures.
• 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 ICH guidelines

EDUCATION AND EXPERIENCE:

• PhD, MD or Bachelors in medical or life science, regulatory science, or related field.
• Strong understanding of FDA/ICH guidelines and processes.
• Minimum of seven (7)+ years progressive experience in pharma/biopharma clinical operations.
• Experience with biologics/gene therapy is preferred.
• Medical writing experience 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).

EOE MFDV