Director, Clinical Operations

POSITION SUMMARY:

Reporting to the Head of Clinical Operations, the Director, Clinical Operations provides strategic and operational leadership for Rigel's clinical operations activities and is accountable for the planning and execution of assigned clinical program(s). This leader contributes to translating development plans into executable operational strategies and ensures their assigned clinical programs are delivered with quality, speed, fiscal discipline, and regulatory compliance.

The Director works closely with Clinical Development, Biometrics, Regulatory Affairs, Drug Safety, Clinical Quality Assurance, Medical Affairs, Clinical Pharmacology, CMC, Finance, Legal, and other functions to coordinate clinical program execution. This leader represents Rigel with CROs, functional service providers, investigators, and other external stakeholders for their assigned clinical program(s). The role maintains oversight of trial performance, budgets, vendors, risk management, inspection readiness, and the integrity of operational data and documentation for their assigned clinical program.

Regular onsite presence is required to support cross-functional collaboration, team engagement, and business operations. Employees designated as onsite or hybrid who reside within the local commuting area are expected to work onsite at Rigel's South San Francisco headquarters during normal business hours each Wednesday and Thursday. Employees designated as remote are expected to work onsite during normal business hours for a minimum of two Wednesday/Thursday business-day periods per month, as scheduled with management, and more frequently as business needs require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead the end-to-end operational management of assigned clinical programs, including feasibility, country and site strategy, study start-up, enrollment, conduct, monitoring, data cleaning, closeout, and Trial Master File completeness.
• Work closely with the Head of Clinical Operations and other key functions, both internally and externally, to ensure successful completion of all clinical program activities and deliverables within the required timeframe and budget.
• Contribute to scenario planning, forecasting of timelines, estimation of resources and budget, and development of operational strategies for assigned clinical programs.
• Provide operational input into protocols, clinical development plans, investigator materials, informed consent forms, study plans, and other key clinical and regulatory documents to improve feasibility and execution.
• Maintain oversight of operational quality, protocol compliance, monitoring, investigator and site performance, essential document management, and Trial Master File health.
• Responsible for selection of and effective management of CROs, vendors, and clinical suppliers, with functional input.
• Partner with Clinical Quality Assurance to maintain clinical program inspection readiness, address significant findings, and ensure timely implementation of corrective and preventive actions.
• Ensure clinical program activities comply with ICH/GCP, applicable FDA and global regulatory requirements, Rigel SOPs, and accepted industry standards.
• Contribute to the development of Clinical Operations departmental processes, SOPs, work instructions, training, and knowledge-management practices to adhere to Rigel's standards, and to all applicable global regulations and guidelines.
• Manage assigned Clinical Operations team/resources, as well as recruitment and training of future team members (i.e., FTEs and consultants/contractors).
• Comply with corporate policies and procedures and support Rigel’s Core Values.
• Other tasks or responsibilities as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor's degree is required in life sciences, nursing, pharmacy, public health, or a related scientific or health discipline. A master's degree or higher in health-related science or equivalent preferred.
• Minimum of 12 years of progressively responsible clinical operations and drug development experience within biotechnology, pharmaceutical, and/or clinical research organizations. Or professional clinical operations experience and advanced degree.
• Strong experience in oncology clinical development is mandatory; experience in hematological malignancies is preferred.
• Experience leading global clinical trials across Phase I through Phase III, including responsibility for study planning, start-up, enrollment, monitoring, execution, database readiness, closeout, and Trial Master File oversight.
• Demonstrated experience overseeing CROs and specialty vendors, including selection, contracting, performance management, issue resolut