Director Clinical Operations

We are seeking a Clinical Operations Lead to drive the planning, execution, and oversight of early-phase oncology clinical trials within a fast-paced, resource-lean startup environment. This role is both strategic and hands-on, driving study plans through to execution while managing CROs, vendors, timelines, and study quality. The ideal candidate brings deep oncology experience, demonstrates flexibility in a dynamic setting, and provides strategic direction while staying closely engaged in day-to-day study operations. As one of the first clinical operations hires, this leader will shape operational processes, ensure inspection-ready execution, and contribute directly to the success of first-in-human and early-development programs.Key ResponsibilitiesClinical Trial ExecutionLead and support the planning, initiation, execution, and close-out of clinical trials (Phase I–III)Manage day-to-day clinical operations activities while ensuring timelines, quality, and budget adherenceCoordinate cross-functional teams (clinical monitoring, data management , biostatistics, regulatory, safety)Track enrollment, site performance, and operational KPIsIdentify operational risk s and implement mitigation strategiesSelect, manage, and oversee CROs and vendorsReview and approve monitoring reports, metrics, and deliverablesOversee deliverables, quality, timelines, and budget adherenceDrive CROs to achieve project deliverables in alignment with internal project goalsEnsure CRO teams are trained, aligned and performing to expectationsServe as the primary operational point of contact for external partnersGlobal Regulatory & ComplianceEnsure trials are conducted in compliance with ICH-GCP, FDA, MHRA, EMA, and local regulationsSupport regulatory submissions and approvals in the US and Ex-US (e.g., IND/CTA)Oversee Trial Master File (TMF) completeness and inspection readinessSite ManagementSupport site selection, initiation, and ongoing site managementCollaborate with investigators and site staff to address enrollment, compliance, and quality issuesIdentify and mitigate operational risks impacting site performanceBudget ManagementSupport development and management of study budgetsTrack actuals vs. forecast, identify variances, and recommend corrective actions to maintain financial discipline.Participate in vendor budget negotiations and ensure cost assumptions are clear, justified, and aligned with study needs.Analytical & Strategic ThinkingSkilled in risk management, timeline forecasting, and operational problem-solving.Ability to interpret data and make evidence-based decisions.Cross-Functional CollaborationWork closely with Clinical Development, Regulatory Affairs, and Data and Safety ManagementProvide operational input into protocol design, feasibility, and study budget and timelinesContribute to process development and continuous improvement in a startup settingRequired QualificationsBachelor's degree in life sciences or related field (advanced degree preferred)10+ years of hands-on clinical operations experience (flexible based on seniority)Experience in execution of oncology clinical trialsDirect experience managing clinical trials in the US and Ex-USStrong knowledge of ICH-GCP and global clinical trial regulationsProven ability to work independently and manage multiple prioritiesExperience working in a startup or small biotech environmentPreferred QualificationsExperience across multiple trial phases (Phase I–III)Prior involvement in inspections or audits (FDA, EMA, MHRA)Ability to build and improve clinical operations processes from the ground upHands-on, execution-focused mindsetStrong organizational and project management skillsExcellent communication and presentation skills and stakeholder management abilitiesProactive problem-solver comfortable with ambiguityTeam-oriented with a strong sense of ownershipWhy Join UsOpportunity to make a direct impact on clinical programs and patientsHigh visibility and responsibility in a growing startupJ-18808-Ljbffr