Associate Director, Clinical Operations

Precision Biosciences•Durham, NC

4h•Hybrid

About The Position

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.

Requirements

Bachelors 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

Nice To Haves

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

Responsibilities

Serve as Clinical Operations Study Lead for Phase 13 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