Sr. Director, Clinical Operations

Torque Bio is an ambitious biotechnology startup developing next-generation genetic medicines for serious kidney disease. The company is advancing a platform that brings together proprietary kidney-optimized AAV vectors, gene replacement and AAV:circular RNA technologies, and targeted local delivery to the kidney. Torque Bio’s initial focus is autosomal dominant polycystic kidney disease, a leading genetic cause of kidney failure with significant unmet need.
POSITION SUMMARY
Torque Bio is seeking an experienced Senior Director of Clinical Operations to build and lead the company’s clinical operations function, including clinical trial management, clinical supply operations, and outsourced study execution across the development portfolio. Reporting, directly to the Chief Medical Officer, this leader will establish the systems, vendor partnerships, and governance models needed to advance novel genetic medicine programs from IND through first-in-human and proof of concept studies
KEY RESPONSIBILITIES
CLINICAL OPERATIONAL STRATEGY
• Develop and execute Torque Bio’s clinical operations strategy aligned with corporate objectives, development milestones, financing plans, and regulatory timelines.
• Build and lead the Clinical Operations function, including clinical trial management, clinical supply operations, and external study execution capabilities.
• Establish operational plans, budgets, timelines, resourcing models, performance metrics, and risk management strategies for all clinical programs.
• Serve as the accountable operational leader for clinical study planning, execution, escalation management, and cross-functional alignment.
CLINICAL TRIAL MANAGEMENT AND STUDY EXECUTION
• Provide strategic and operational leadership for early- and later-stage clinical studies, beginning with first-in-human execution and proof-of-concept studies.
• Oversee study startup, country and site selection, site activation, enrollment, monitoring, study conduct, database lock, and study closeout activities.
• Ensure studies are delivered in accordance with protocol requirements, regulatory expectations, budget, timeline, and quality objectives.
• Establish clinical trial governance processes, escalation pathways, operational dashboards, and study performance review forums.
CLINICAL SUPPLY OPERATIONS
• Partner with CMC, Quality, Regulatory, and external partners to develop and execute clinical supply strategies for genetic medicine programs.
• Oversee clinical supply planning, demand forecasting, labeling, packaging, distribution, depot management, inventory tracking, temperature monitoring, and site-level readiness.
• Ensure clear operational interfaces across manufacturing, quality release, logistics, pharmacy/site preparation, investigational product accountability, and study execution.
• Support planning for complex administration procedures, site training, cryogenic or temperature-controlled logistics where applicable, and chain-of-custody/chain-of-condition requirements.
CRO AND VENDOR MANAGEMENT
• Develop and manage a high-performing network of CROs, clinical supply vendors, central laboratories, imaging providers, specialty logistics providers, patient recruitment partners, and other external service providers.
• Lead vendor identification, qualification, selection, contracting input, governance, performance management, and issue escalation activities.
• Establish scalable oversight frameworks for outsourced clinical development activities in a lean operating model.
CLINICAL TRIAL PLANNING, FEASIBILITY, AND ENROLLMENT
• Lead protocol operational assessments, feasibility analysis, enrollment forecasting, country/site selection, and study startup strategies.
• Develop practical approaches to patient identification, recruitment, retention, and site engagement, particularly within rare disease and kidney disease populations.
• Provide operational input into protocol design to improve feasibility, investigator experience, patient burden, data quality, and execution efficiency.
• Assess decentralized or hybrid trial tools, clinical technologies, and novel operational models when appropriate for the program and patient population.
INSPECTION READINESS, QUALITY, AND COMPLIANCE
• Ensure clinical programs are conducted in compliance with applicable GCP regulations, ICH guidelines, FDA regulations, EU requirements, and other regional expectations.
• Partner closely with Quality Assurance to maintain inspection readiness across clinical operations, clinical supply operations, vendor oversight, and essential documentation.
• Oversee quality management activities related to clinical operations, including deviations, CAPAs, audit responses, issue escalation, and risk assessments.
• Support regulatory inspections, sponsor audits, and partner audits as appropriate.
CLINICAL OPERATIONS INFRASTRUCTURE AND SYSTEMS
• Establish scalable SOPs, templates, study plans, dashboards, meeting structures, and governance processes supporting clinical execution.
• Oversee implementation and effective use of CTMS, eTMF, EDC, IRT/randomization systems, safety reporting interfaces, clinical supply tracking tools, and clinical analytics platforms.
• Develop resource planning, budget forecasting, accrual tracking, and scenario planning capabilities.
• Maintain organizational readiness for portfolio growth, additional indications, expanded geographies, and later-stage clinical development.
REQUIRED QUALIFICATIONS
EDUCATION
• Bachelor’s degree in life sciences, nursing, pharmacy, public health, healthcare administration, or related discipline required.
EXPERIENCE
• 10+ years of progressive clinical operations experience within biotechnology, pharmaceutical, biologics, rare disease, gene therapy, RNA therapeutics, or advanced therapy organizations.
• Minimum 3-5 years of senior clinical operations leadership experience, including direct accountability for clinical study execution and vendor oversight.
• Demonstrated success leading programs from IND activation through first-in-human execution and key clinical development milestones.
• Experience operating within lean, outsourced clinical development models is critical.
• Prior experience building or scaling clinical operations capabilities within an emerging biotechnology company strongly preferred.
• Experience in rare disease, nephrology, gene therapy, or other advanced modalities strongly preferred.
WHAT YOU BRING
• Deep understanding of ICH-GCP, FDA regulations, EU Clinical Trial Regulation, and global clinical development requirements.
• Strong expertise in CRO oversight, vendor governance, clinical trial management, enrollment planning, and risk-based trial management.
• Experience partnering with CMC, Quality, and external vendors on clinical supply planning and investigational product logistics.
• Experience supporting regulatory inspections, sponsor audits, and inspection readiness activities.
• Demonstrated excellence in study startup, site activation, enrollment management, budget oversight, and operational execution.
• Experience with electronic clinical systems, including CTMS, eTMF, EDC, IRT/randomization, safety systems, and clinical analytics platforms.
Equal Opportunity Employer
Torque Bio is an equal opportunity employer and is committed to building a diverse and inclusive workplace. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by applicable federal, state, or local law. All qualified applicants will receive consideration for employment without regard to any of these protected characteristics.

Work arrangement
Yes