Job Description
ABOUT THE ROLE Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-impact leader who will drive the operational engine behind our HMB-002 program. This is not a role for a manager of the status quo. We are looking for a builder, a problem-solver, and an innovator who raises the bar on execution. You will sit at the center of Hemab's clinical strategy and execution, owning end-to-end delivery across a growing global portfolio, from first-in-human studies to pivotal trials, while continuously finding smarter, faster, and more patient-centric ways to operate. You will report to the VP Clinical operations and dotted line directly to the CEO. Boston-based, hybrid with a min of 2-3 days in office KEY RESPONSIBILITIES Operational Excellence & Study Delivery Drive innovative, creative and efficient trial design and optimization Accountability for trial start, recruitment, enrollment and end to end execution. Represent Clinical Operations on the Asset Team and Clinical Strategy Subteam, contributing strategic and operational input on the HMB-002 clinical development plan Own end-to-end operational execution of clinical trials from protocol finalization through clinical study report; ensuring delivery on time, within budget, and to the highest quality standards Drive rigorous planning and accountability across all functions: define milestones, manage risks proactively, and resolve operational issues with urgency and precision Build and evolve fit-for-purpose processes, standards, and operating procedures that scale with the organization and reflect industry best practice Establish and maintain transparent, data-driven reporting mechanisms to keep executive leadership and cross-functional teams fully informed on trial status, risks, and performance metrics Lead budget ownership across the program including forecasting, tracking, and actively managing spend to ensure financial discipline without compromising quality or speed Innovation & Continuous Improvement Proactively identify and implement process innovations including novel trial designs, technology platforms, and decentralized/hybrid trial elements to accelerate timelines and improve patient access. Champion the adoption of clinical technology solutions (eTMF, EDC, CTMS, patient engagement platforms) that drive operational efficiency and data quality Apply lessons learned systematically across programs; lead a culture of retrospective analysis, iteration, and continuous improvement Explore and evaluate emerging industry trends, regulatory innovation pathways, and operational models to keep Hemab at the forefront of rare disease trial execution Vendor & Site Management Identify, select, and manage study partners and external consultants with high expectations for performance, accountability, and alignment with Hemab's standards Lead constructive, trust-based partnerships with investigative sites globally — ensuring clear plans, milestones, and open communication to maximize enrollment performance and data quality Develop and execute robust resourcing and oversight plans for clinical trials, including risk-adapted monitoring strategies Regulatory Quality & Compliance Ensure all trials are conducted in strict accordance with ICH/GCP requirements, applicable regulations, and Hemab's SOPs and quality standards Participate in the development of critical regulatory and study documents: protocols, ICFs, investigator brochures, clinical study reports, and INDs/CTAs Leadership & Cross-Functional Collaboration Serve as a key functional leader and subject matter expert across the organization, effectively partnering to execute clinical studies and development strategy Build, mentor, and inspire a high-performing clinical operations team; develop talent at all levels and cultivate a culture of excellence, accountability, and innovation Actively shape departmental and corporate strategy, bringing operational insight and foresight to leadership discussion Promote collaboration and creativity within Clinical Operations to drive standardization, efficiency, cost management, and sustainable solutions for long-term clinical development Join and represent the asset at board of directors meetings for updates and reviews
