Associate Director, Clinical Operations

Summary

The Associate Director, Clinical Operations will play a key leadership role in the planning, execution, and oversight of clinical trials, with a primary focus on rare neuromuscular diseases, including Duchenne Muscular Dystrophy (DMD). This individual will serve as a study lead across one or more clinical programs and will be accountable for operational excellence, cross-functional coordination, vendor oversight, and patient-centric trial execution.

This role requires deep experience in DMD and/or rare disease clinical trials, strong operational judgment, and a demonstrated commitment to patient advocacy. The Associate Director, Clinical Operations will work closely with internal stakeholders, CROs, investigators, and patient advocacy organizations to ensure trials are conducted efficiently, compliantly, and with sensitivity to the needs of pediatric and adult patients and their families.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Serve as Clinical Operations Study Lead for Phase 1–3 clinical trials, with primary responsibility for rare neuromuscular disease programs, including Duchenne Muscular Dystrophy (DMD)
• Lead end-to-end study execution from feasibility and start-up through close-out, ensuring operational excellence, timeline adherence, budget control, and regulatory compliance
• Provide strategic and hands-on leadership for study start-up activities, including site feasibility, site selection, site initiation, and activation across domestic and international sites
• Oversee CROs and functional vendors, including central laboratories, specialty assay vendors, imaging vendors, functional assessment vendors, wearable technology providers, and home-health service providers
• Lead operational readiness and execution for central and specialty laboratory testing, including immunogenicity, biomarker, pharmacokinetic, safety, and vector-shedding assays; ensure appropriate test menus, sample handling workflows, shipment logistics, and site training are in place prior to first patient enrollment
• Coordinate closely with Translational Science, Biomarkers, Clinical Development, and CMC teams to support assay and laboratory start-up, data flow, and protocol-aligned execution
• Provide operational oversight for complex efficacy and functional endpoints, including age-appropriate motor and developmental assessments; ensure consistent execution, vendor oversight, and data quality across all sites
• Lead operational planning, vendor coordination, and site training for functional testing and performance outcomes, including but not limited to NSAA, timed/performance outcomes, Bayley Scales of Infant and Toddler Development (Bayley-4), and wearable-derived digital mobility endpoints
• Oversee video-based assessments, including vendor selection, site training, data collection workflows, and quality review
• Lead operational coordination for specialized procedures, including muscle biopsies (anesthesia coordination, scheduling, central pathology workflows), cardiac MRI, skeletal muscle qMRI, echocardiography, ECGs, and pulmonary function testing
• Ensure protocol-compliant execution of intensive safety monitoring, immune modulation regimens, and high-frequency laboratory assessments in early-phase gene therapy or gene-editing trials
• Develop and manage study timelines, budgets, forecasts, and change orders, including oversight of site budgets, CTAs, and vendor contracts
• Lead cross-functional review of protocols, amendments, informed consent forms, and patient-facing materials, ensuring feasibility and operational clarity
• Embed patient-centric and patient advocacy principles into trial design and execution, with sensitivity to pediatric populations and caregiver burden
• Support DMC/DSMB activities and safety governance, including meeting preparation, data review coordination, and implementation of committee recommendations
• Ensure inspection readiness and quality compliance, including support for audits, health authority inspections, and internal quality initiatives
• Mentor and develop Clinical Operations team members and contribute to continuous improvement of Clinical Operations processes and standards

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• Bachelor’s degree in life sciences or a related field and 8+ years of progressive clinical operations experience, including study leadership responsibility
• Direct experience supporting rare disease and/or neuromuscular clinical trials, with strong preference for Duchenne Muscular Dystrophy experience
• Demonstrated experience leading early-phase and/or Phase 1/2 clinical trials, including complex start-up and intensive safety monitoring
• Hands-on experience coordinating central and specialty laboratories, including immunogenicity, biomarker, PK, and safety assays
• Proven experience operationalizing complex efficacy and functional endpoints, including functional testing, imaging, and wearable or digital endpoints
• Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial conduct
• Demonstrated ability to manage CROs and multiple functional vendors in a matrixed, cross-functional environment

Preferred:

• Experience in gene therapy, gene editing, or other advanced therapeutic modalities
• Pediatric clinical trial experience, including oversight of age-gated assessments and caregiver-facing study procedures
• Direct engagement with patient advocacy organizations and demonstrated commitment to patient-centric trial execution

Travel Requirements

• Travel to clinical sites will be expected to support study activities, along with occasional travel to conferences and meetings, as needed.

Location

• Office-based with hybrid/remote flexibility per company policy.

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing in vivo gene correction therapies for genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.