Head of Clinical Operations ( On site role)

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Head of Clinical Operations ( On site role)

Regular Full Time Executive - VP Maryland, Germantown, MD, US

7 days ago Requisition ID: 1405

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 Operation 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.

DUTIES AND 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 enrollmentcurves,timelines,analysisofthestudystatusandidentificationofpotentialrisks)Clinical Trial material (CTM) Management, budget, and finances, change orders,contracts.
• Provide Clinical Operations expertise in cross-functional meetings and works closely with cross functionalmemberstoensurethequalityandinaccordancewithPrecigenSOPsandglobal regulatoryguidelines

EDUCATION AND EXPERIENCE

• PhD, MD or Bachelors in medical or life science, regulatory science, or relatedfield.
• Strong understanding of global regulatory guidelines andprocesses.
• Minimum of ten (10)+ years progressive experience in pharma/biopharma clinicaloperations.
• Experience with biologics/gene therapy ispreferred.

DESIRED KEY COMPETENCIES

• Ability to understand and execute on the company’s mission andvalues.
• Exceptional organization skills with strong attention todetail.
• Strong personal leadership andself-direction.
• Clear communication in both oral and writtenform.
• Demonstrated ability to work with and coordinate demands from multiplestakeholders.
• Exhibition of the highest degree of ethical standards andtrustworthiness.
• Advanced skills in Microsoft Word, Adobe Acrobat Professional®, and clinical trialmanagement systems(CTMS).