Associate DIrector/Director, Clinical Operations | REMOTE

Associate Director / Director, Clinical OperationsOverviewThe organization is dedicated to developing therapies that address significant unmet needs in autoimmune disease. The Associate Director / Director, Clinical Operations will help lead the operational execution of the company's global clinical development programs. Building on a strong hands-on foundation in clinical trial management, this role carries accountability for the end-to-end operational delivery of one or more studies (Associate Director) or a full clinical program (Director) — including operational strategy, timelines, budget, vendor oversight, quality, and the leadership and development of the in-house clinical operations team. Operating within a lean, fast-paced environment, the successful candidate will be both a strategic leader and an engaged operator who sets direction while remaining close enough to the detail to anticipate risk and drive issues to resolution.ResponsibilitiesStudy & Program LeadershipOwn the operational strategy and end-to-end execution of one or more clinical studies (Associate Director) or an entire clinical program (Director), spanning startup, conduct, database lock, and close-out.Develop and maintain integrated study timelines, operational plans, and budgets; proactively identify critical-path risks and lead contingency planning to keep programs on track.Serve as the clinical operations lead on cross-functional study teams, partnering with Clinical Development, Regulatory, Biostatistics, Data Management, Pharmacovigilance, Medical, and Clinical Supply to align operational delivery with development objectives.Represent clinical operations in interactions with senior leadership and contribute to program-level planning and decision-making.Team Leadership & DevelopmentLead, mentor, and develop the in-house clinical operations team, including Clinical Research Associates and, as the team grows, Clinical Trial Managers and other operations staff.Set performance expectations, manage workload and capacity across studies, and build team capabilities and bench strength.Foster a culture of ownership, quality, and proactive problem-solving consistent with a lean biotech environment.Vendor, CRO & Budget OversightLead the selection, onboarding, and governance of CROs and specialty vendors; define scopes of work, oversight models, and performance metrics, and hold vendors accountable to deliverables.Own study/program budgets, including forecasting, accrual tracking, and review of vendor invoices and change orders; partner with Finance and senior leadership on resourcing decisions.Operational Execution & QualityOversee development of study operational manuals and plans — including the Clinical Monitoring Plan, Protocol Deviation Handling Guide, and related guidance — and ensure adherence across the study team and vendors.Provide oversight of monitoring activities (in-house and/or outsourced), including review and approval of monitoring trip reports, IP release checklists, protocol deviations, aging action items, and critical/aging queries; ensure issues are escalated and resolved.Contribute to and provide senior review of study protocols, informed consent forms, pharmacy manuals, eCRF entry manuals, eTMF and filing plans, and other study-related documentation.Direct site feasibility and selection strategy; oversee site initiation and interim monitoring, and conduct onsite visits as needed.Oversee the design and delivery of clinical operations training, including CRA, study coordinator, investigator meeting, and SIV training.Ensure timely document collection, filing, access control, and quality control within the electronic Trial Master File (eTMF).Quality, Compliance & Inspection ReadinessDevelop and own Key Clinical Quality Indicators and risk-based oversight processes that surface monitoring and site-adherence risks; establish routine review, escalation, and resolution cadences.Own or co-own the study/program inspection readiness program in partnership with Quality Assurance, including real-time storyboard development, eTMF quality, and audit/inspection support and CAPA management.Ensure trials are conducted in accordance with ICH-GCP, applicable global regulations, and company SOPs; contribute to the development and continuous improvement of departmental SOPs, systems, and processes.Qualifications10+ years of clinical operations experience (Director) or 8+ years (Associate Director), including direct line management of clinical operations staff (e.g., CRAs and/or CTMs).Demonstrated experience leading the operational delivery of clinical studies end-to-end, including CRO/vendor oversight, budget ownership, and timeline accountability.Strong command of all key aspects of global clinical trial operations across startup, conduct, and close-out.Working knowledge of ICH-GCP and applicable global regulatory requirements; experience supporting regulatory inspections preferred.Proven ability to lead cross-functional teams and influence in a matrixed environment.Demonstrated ability to prioritize, organize, plan, and deliver results across multiple studies and projects simultaneously.Self-starter with a strong sense of ownership who thrives in a lean, fast-paced, nimble environment and is comfortable managing uncertainty and contributing hands-on.Experience in autoimmune or immunology therapeutic areas a plus.Travel of approximately 25–35%, varying with study phase (for example, increased during startup and database lock).BA/BS required; advanced degree (MS, PharmD, PhD) or relevant certification (e.g., CCRA, PMP) a plus.