Neomorph, Inc.
Job Description
About the Role The Director of Clinical Operations is responsible for strategic leadership and oversight of the company’s clinical trial portfolio to ensure programs are executed in accordance with protocols, regulatory requirements, ICH-GCP guidelines, and company SOPs. This role reports to the VP of Clinical Operations and partners closely with Clinical Development and senior cross‑functional leaders to drive high‑quality, timely, and cost-effective clinical trial delivery that supports the company’s development and registration strategy. The Director will provide strategic direction to internal clinical operations staff and external partners, oversee CRO and vendor performance, and play a key role in shaping and scaling the Clinical Operations function as the company grows. This is a hybrid position based at our San Diego site. Key Responsibilities Clinical Operations Strategy & Portfolio Leadership Provide strategic oversight of clinical operations across one or more programs, from first-in-human through late-stage development. Translate clinical development plans into operational strategies, including scenario planning, timelines, and resourcing for assigned programs. Lead integrated operational planning for studies, ensuring alignment across clinical, regulatory, biometrics, safety, and CMC functions. Identify program- and study-level risks and interdependencies, and implement proactive mitigation strategies to maintain program and study timelines. Clinical Trial Management Oversee the end-to-end operational management of clinical trials from start-up through close-out, ensuring delivery on time, within budget, and with high data quality. Ensure robust study plans, timelines, and tracking tools are in place and utilized to monitor progress and performance across trials. Provide leadership and guidance to team members responsible for day-to-day trial execution, ensuring operational excellence and compliance. CRO and Vendor Oversight Lead the strategic and operational oversight of CROs, clinical vendors, and consultants at the program and study level, ensuring accountability for timelines, quality, and budget adherence. Drive vendor selection, RFP processes, scope definition, and contract negotiations in partnership with Clinical Operations leadership, Legal, and Finance. Establish and monitor performance metrics (KPIs) for CROs and key vendors, and participate in both governance and routine meetings to review performance and address issues. Site Management and Monitoring Oversight Oversee site strategy across a given program, including site selection, activation, enrollment, and retention plans, in collaboration with CRO partners. Review aggregate site and monitoring metrics (enrollment, data quality, query rates, protocol deviations) and drive corrective and preventive actions as needed. Ensure Sponsor oversight of clinical study site and monitoring activities. Champion and execute on site and investigator engagement strategies to optimize enrollment, patient experience, and site relationships. Study Start-Up and Regulatory Support Provide strategic input into study start-up plans, including feasibility, country and site selection, and regulatory submission strategies. Provide operational oversight during study start-up ensuring study site and CRO alignment with Sponsor requirements, including review of clinical trial agreements, budgets, and informed consent forms. Oversee regulatory vendors to ensure completion of maintenance submissions, ensuring high-quality operational input into key documents and health authority responses. Ensure inspection-readiness of programs and studies through robust documentation, training, and quality oversight. Budget and Financial Oversight Own or co-own clinical operations budgets at the program and/or study level, including forecasting, accruals, and scenario planning. Oversee review and approval of CRO and vendor budgets, SOWs, and change orders to ensure alignment with operational plans and contracts. Oversee review and approval of study site budgets and amendments to ensure alignment with operational plans. Monitor clinical trial expenditures, identify variances, and implement plans to keep programs within budget while maintaining quality and timelines. Compliance and Quality Ensure that all clinical trials are conducted in full compliance with ICH-GCP, global regulatory requirements, and company SOPs. Partner with Quality Assurance to support audits and inspections and lead resolution of clini