Director, Clinical Operations

Description DIRECTOR, CLINICAL OPERATIONS Job Summary The Director, Clinical Operations, is responsible for the strategic planning, oversight, and execution of assigned clinical trials, ensuring adherence to approved study timelines and budget while maintaining the highest standards of quality. Key Roles And Responsibilities Overall study execution of one or more complex clinical trials, including global clinical trials. Develop study timelines. Lead study start-up, general study management, and close out, including ongoing CRO performance management and quality oversight Develops and executes clinical operational strategy aligned with corporate objectives Reviews and provides technical input on key clinical documents (protocols, ICFs, IB, CSRs, etc.) Serves as the primary point of escalation for CRO and vendor issues, leading risk mitigation efforts and driving timely resolution. Responsible for the overall quality of the TMF for assigned clinical trials. Ensure all study documents are collected, inventoried, and filed in accordance with ICH GCP and sponsor requirements. Assist in the preparation and follow-up of in-house and on-site clinical site and study vendor quality audits, as well as regulatory authority inspections. Develop requirements/specifications for outsourcing to vendors. Works with the Program Management team to review vendor proposals, contracts, scope changes/change orders, and budgets for accuracy with respect to the clinical trial protocol and trial activities. Reconcile vendor invoices for accuracy as needed. Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) and other vendor activities to confirm the integrity, accuracy, and accountability of trial activities. Oversee clinical and research lab data, ensuring compliance with the protocol and study manuals, Coordinate with CRO and data management for database cleaning, interim lock, and final database lock, and ensure data timelines are met. Participate in reviewing tables, listings, and figures for the interim analysis or the final data output. Coordinate with the CMC team for investigational product (IP) supply management activities and resolution of IP issues identified at clinical sites during clinical trial. Compile clinical trial operations materials and updates for consultants, Scientific Advisory Board, and Curevo Board of Directors. Contributes to the development of abstracts, presentations, manuscripts, and other external forms of communication. May represent Clinical Operations at cross-functional meetings, CRO Governance Meetings, Senior Leadership Team meetings, and Board of Directors Meetings. Foster collaborative relationships with internal and external stakeholders, including Clinical investigators, KOLs, CROs, and other outside parties. Identify opportunities for improving the efficiency and effectiveness of clinical trial operations, develop strategic recommendations, and lead process improvement initiatives to enhance overall performance and execution. Working with the Head of Clinical Operations, assist in department-level resource planning Hire, manage, and coach a team of clinical operations personnel Other activities may be assigned as required Required Qualifications BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy). Minimum of 10 years clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO, with at least 5 of those years having overall responsibility for managing clinical trial studies Experience with management of CRO across large global trials, including oversight of performance and quality metrics Experience in the set-up and management of third-party vendors. Experience with phases I, II, and III clinical trials. Experience executing phase III, global clinical trials within approved timelines and budget Preferred Qualifications Experience supporting regulatory submissions and participating in Health Authority inspections Knowledge, Skills, And Abilities Thorough knowledge of FDA, CFR, and ICH GCP requirements and other regulatory requirements. Demonstration of exceptional clinical trial management, with strong strategic oversight to ensure program execution is delivered on time and within budget. Proven interpersonal skills with the ability to build strong relationships cross-functionally and with external stakeholders, including clinical sites, vendors, consultants, and CROs. Proven leader