Director, Clinical Operations

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 and lead study start‑up, general study management, and close out, including ongoing CRO performance management and quality oversight. Develop and execute clinical operational strategy aligned with corporate objectives. Review and provide technical input on key clinical documents (protocols, ICFs, IB, CSRs, etc.). Serve as the primary escalation point for CRO and vendor issues, lead risk mitigation efforts and drive timely resolution. Ensure overall quality of the Trial Master File (TMF) for assigned trials; all study documents collected, inventoried, and filed in accordance with ICH GCP and sponsor requirements. Assist in preparation and follow‑up of in‑house and on‑site clinical site and study vendor quality audits, and regulatory authority inspections. Develop requirements/specifications for outsourcing to vendors; review vendor proposals, contracts, scope changes, and budgets with the Program Management team. Reconcile vendor invoices for accuracy as needed. Oversee clinical monitoring (site qualification, site initiation, interim monitoring, close‑out 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 lock; participate in reviewing tables, listings, and figures for interim or final data output. Coordinate with the CMC team for investigational product (IP) supply management activities and resolution of IP issues identified at clinical sites. Compile clinical trial operations materials and updates for consultants, Scientific Advisory Board, and Board of Directors. Contribute to development of abstracts, presentations, manuscripts, and other external communications. 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 investigators, 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. Assist in department‑level resource planning with the Head of Clinical Operations. Hire, manage, and coach a team of clinical operations personnel. Other activities may be assigned as required. Required Qualifications BS degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 10 years clinical trial experience in the pharmaceutical, biotech, clinical trial site, or CRO; at least 5 years with overall responsibility for managing clinical trial studies. Experience managing CROs across large global trials, including performance and quality metric oversight. 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, ICH GCP, and other regulatory requirements. Demonstrated exceptional clinical trial management with strong strategic oversight to deliver programs on time and within budget. Proven interpersonal skills to build strong relationships across functions and with external stakeholders. Proven leadership and team‑building skills; ability to build, manage, coach, and motivate teams. Demonstrated success in proactive risk mitigation and implementation of innovative solutions. Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) and electronic systems (CTMS, EDC, eTMF); experience with Smartsheet desirable. Flexibility in work hours to accommodate international collaborators or significant meetings/events. Up to 25% travel (US and international) may be required. Physical Demands Performing job responsibilities requires the use of hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, stoop, kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. May occasionally lift, tug, and pull up to 25 lbs. Work Environment This job operates in a professional office environment. The role routinely uses standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines. Compensation and Benefits Salary: $220,000 – $235,000 annually, subject to company policies and applicant qualifications. Annual discretionary bonus potential. Eligibility for Discretionary Equity Awards Plan. Medical, dental, and vision plans effective the first of the month following hire. Flexible Spending Account, Health Savings Account, life and AD&D insurance, LTD insurance. 401(k) plan with company match starting day one. Cell phone reimbursement and other supplemental benefits. Flexible vacation plan, paid sick leave, 10 paid holidays per year, and 1 hour sick time earned for every 30 hours worked. Up to 25% travel (U.S. and international) may be required. Equal Opportunity Employer Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws. #J-18808-Ljbffr TSP, a Syneos Health company