Senior Director/Executive Director, Clinical Operations
275 Shoreline Drive, suite 100 Redwood City, CA 94065
The Senior Director, Clinical Operations is responsible for leading Clinical Operations activities. In addition, this role will be responsible for the mentoring and management of other clinical operations staff.
? Oversee functional deliverables to support program objectives as defined in the Clinical Development Plan
? Ensures timely execution of clinical research programs/protocols from conception through final clinical study report.
? Ensure that clinical studies are properly resourced, managed, and executed within budget, and in accordance with established timelines and quality standards
? Oversees all activities of assigned Clinical Operations team in clinical trial management (from study start up to study closure); including vendor and site start-up, ongoing trial management, including TMF and risk management evaluation
? Selection of CROs and direct management of CRO activities performed on behalf of Kartos
? Maintains budget planning/forecasting and clinical trial metrics
? Contributes to clinical trial design and implementation planning to ensure optimized clinical development plans for assigned projects.
? Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
? Identify to management risks to study implementation, enrollment, conduct, compliance, and completion
? High-level oversight of trial data, i.e., data flow from the sites (CRF completion), to data entry (CRFs entered in database), to data listing review
? Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
? Leads Clinical Operations team meetings and ensures knowledge sharing and consistency across department.
? Ensure departmental operational consistency across multiple studies, CROs, and vendors
? Provides leadership, including mentoring, management, development and support to staff to ensure all clinical trials are operationalized and managed in alignment with strategy and compliance standards
? Responsible for ensuring compliance with SOPs and Work Instructions, FDA and global regulations, International Committee for Harmonisation (ICH) guidelines, and GCP
? Represent Clinical Operations in cross-functional projects
Qualifications and Requirements
? BS/MS in a scientific discipline or equivalent experience. Advanced degree preferred
? Extensive Clinical operations experience in the pharmaceutical/biotech industry
? Direct and in-direct management experience
? Experience leading programs from preclinical to IND submission preferred
? Oncology/ immuno-oncology experience required
? Experience leading process changes and writing SOPs and other controlled documents
? Understanding of global pharmaceutical regulatory requirements and impact on the execution of clinical trials