Meet Life Sciences is supporting a clinical-stage biotechnology company based in San Diego who are seeking an experienced Senior Director, Clinical Operations to lead the operational strategy and execution of a first-in-human clinical program evaluating an innovative cell therapy for autoimmune disease.
This individual will serve as the clinical operations leader for the program, overseeing study planning, start-up, execution, and closeout while managing CROs, clinical sites, specialty vendors, timelines, and budgets.
The Senior Director will work closely with Clinical Development, Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, CMC, Translational Medicine, and Quality to advance the program through early clinical development.
The ideal candidate will bring significant experience leading early-phase clinical trials within a biotechnology or pharmaceutical company. Experience with cell therapy, autoimmune disease, immunology, or other operationally complex clinical programs is strongly preferred.
Key Responsibilities
Clinical Program Strategy and Leadership
- Develop and execute the clinical operations strategy for a first-in-human cell therapy program in autoimmune disease.
- Translate the clinical development plan and protocol into detailed operational plans, timelines, budgets, and study-specific deliverables.
- Provide clinical operations leadership from protocol development and study start-up through enrollment, database lock, study closeout, and clinical study reporting.
- Identify program-level operational risks and implement proactive mitigation and contingency plans.
- Contribute to broader clinical development, portfolio-planning, and organizational decision-making activities.
- Present study progress, risks, resource requirements, and strategic recommendations to senior leadership.
Study Execution
- Lead the operational implementation of early-phase clinical trials across the United States and potentially international regions.
- Oversee site feasibility, site identification, qualification, selection, activation, enrollment, monitoring, and close out.
- Develop enrollment and site-engagement strategies for complex autoimmune patient populations.
- Partner with Clinical Development and Clinical Science on protocol design, eligibility criteria, study procedures, and operational feasibility.
- Ensure appropriate operational planning for cell collection, manufacturing coordination, product release, chain of identity, chain of custody, shipment, administration, and patient follow-up.
- Establish processes for managing treatment scheduling and coordination across clinical sites, manufacturing teams, couriers, laboratories, and other specialty vendors.
- Ensure clinical trial documentation and systems remain accurate, complete, inspection-ready, and compliant with applicable requirements.
CRO and Vendor Management
- Lead the selection, contracting, onboarding, and oversight of CROs and clinical vendors.
- Establish clear governance structures, performance expectations, escalation pathways, and key performance indicators.
- Manage CRO and vendor performance against contractual obligations, quality standards, budgets, timelines, and deliverables.
- Oversee specialty vendors supporting central laboratories, imaging, sample logistics, cell-processing activities, clinical supplies, data systems, and other study services.
- Lead governance and operational review meetings, documenting decisions, risks, action items, and accountability.
- Partner with Finance, Legal, and Procurement to manage contracts, change orders, accruals, forecasting, and vendor payments.
Cross-Functional Collaboration
- Serve as the primary Clinical Operations representative on cross-functional study and program teams.
- Collaborate with Regulatory Affairs on clinical trial applications, health authority submissions, responses, and regulatory commitments.
- Support the preparation of investigator meetings, site-initiation visits, dose-escalation meetings, safety-review committee meetings, and data-review meetings.
- Contribute operational content to protocols, informed consent forms, investigator brochures, clinical study reports, regulatory submissions, and internal governance materials.
Required Qualifications
- Bachelor’s degree in a scientific, healthcare, nursing, or related discipline; advanced degree preferred.
- Approximately 12 or more years of progressive clinical research or clinical operations experience within the biotechnology, pharmaceutical, or CRO industry.
- At least 5 years of experience leading clinical trials at the sponsor level.
- Demonstrated ownership of Phase 1 or first-in-human clinical studies from start-up through execution and close out.
- Experience managing CROs, clinical vendors, budgets, timelines, and cross-functional study teams.
- Strong working knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements.
- Experience developing operational plans, risk-management strategies, enrollment forecasts, and executive-level study updates.
- Ability to operate effectively within a growing biotechnology company where responsibilities may extend beyond traditional functional boundaries.
- Strong leadership, communication, negotiation, problem-solving, and organizational skills.
- Ability to work from the company’s San Diego-area office on a regular basis and travel as required.
Preferred Qualifications
- Clinical operations experience with cell therapy, gene-modified cell therapy, CAR-T therapy, T-cell engagers, biologics, or other complex therapeutic modalities.
- Experience in autoimmune, rheumatology, immunology, inflammatory disease, or related therapeutic areas.
- Experience with basket studies or trials enrolling patients across multiple autoimmune indications.
- Experience supporting dose-escalation and dose-expansion studies.
- Experience preparing for regulatory inspections or supporting sponsor inspections.
- Previous experience building clinical operations infrastructure, processes, or teams within an emerging biotechnology company.
- Direct people-management experience.
