Director of Clinical Operations — Cell & Gene Therapy

Tr1X, Inc.; San Diego (CA); Sur place; USD 210 000 - 230 000; Plein temps

Avantages offerts par ce poste

401k match

Health insurance

PTO

Stock options

Paid holidays

Résumé du poste

Tr1X, Inc. in San Diego, CA is seeking a Director of Clinical Operations to lead trials from start-up to close-out, manage CRO partners, investigators, and vendors, and ensure trials meet GCP, regulatory, and budget goals.

You will mentor a team, shape study conduct strategies, oversee TMF readiness, and collaborate with Regulatory Affairs to prepare essential submissions, while traveling up to 15% to sites and vendors as needed.

Qualifications

• A minimum of 10 years in clinical operations with at least 5 years in sponsor study leadership.
• Experience leading global or multi-center trials across development phases.
• Exposure to cell or gene therapy trials is preferred.
• Strong knowledge of ICH/GCP, FDA regulations, and global requirements.

Responsabilités

• Provide strategic leadership for cross-functional teams to ensure timely trial start-up, enrollment, and close-out within budget and quality expectations.
• Direct and oversee all aspects of clinical study management for operational excellence and inspection readiness.
• Lead protocol development, amendments, and key study documents with sponsor and CROs.
• Develop CRO/vendor selection strategies, bids, budgets, and executive-level decisions.
• Negotiate contracts and scopes of work with CROs, vendors, and sites.
• Maintain critical study documents and TMF oversight, ensuring accountability and delegation.
• Chair internal and external study meetings and governance reviews.
• Partner with Regulatory Affairs for timely regulatory submissions to FDA and authorities.
• Develop monitoring strategies and data collection methodologies with Data Management and Development teams.
• Oversee site initiation, training materials, and investigator engagement plans.
• Provide governance oversight of CROs, monitors, and vendors to meet contractual obligations.
• Establish monitoring and CAPA processes to maintain quality and compliance.
• Direct study-wide operations including biospecimen handling, logistics, and investigator payments.
• Review data reports to identify trends and communicate to leadership committees.
• Ensure TMF readiness and inspection readiness throughout studies.
• Lead and facilitate program meetings, safety reviews, and cross-functional forums.
• Define operational strategies with leadership for resource planning and process optimization.
• Identify operational risks and implement mitigation to ensure continuity.
• Travel up to 15% to clinical sites and vendors.
• Foster accountability, collaboration, and continuous improvement in a fast-paced environment.
• Perform additional duties to support evolving business objectives.

Connaissances

Clinical operations leadership

Cross-functional leadership

Vendor management

Regulatory knowledge (FDA/ICH/GCP)

Trial management (start-up to close‑up

Pre-NDA / first-in-human experience

Eclinical systems (eTMF, CTMS, EDC)

Strategic planning

Mentoring teams

Communication skills

Formation

Bachelor’s degree in science or healthcare field

Outils

eTMF

CTMS

EDC

Description du poste

Tr1X, Inc. in San Diego, CA is seeking a Director of Clinical Operations to lead trials from start-up to close-out, manage CRO partners, investigators, and vendors, and ensure trials meet GCP, regulatory, and budget goals.

You will mentor a team, shape study conduct strategies, oversee TMF readiness, and collaborate with Regulatory Affairs to prepare essential submissions, while traveling up to 15% to sites and vendors as needed.