Associate Director/Director, Clinical Operations

Associate Director / Director, Clinical Operations

Overview

The 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.

Responsibilities

Study & Program Leadership

• Own 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 & Development

• Lead, 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 Oversight

• Lead 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 & Quality

• Oversee 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 Readiness

• Develop 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.

Qualifications

• 10+ 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.