Senior Director of Clinical Operations – sutacimig program

Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-impact leader who will drive the operational engine behind our sutacimig 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

• 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 sutacimig 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
• 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
• 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

• 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

• 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

Required

• Bachelor's degree or higher in life sciences, biology, or related field
• Strong command of ICH/GCP and international regulatory requirements
• 15+ years of clinical operations/clinical program management experience in pharmaceutical or biotech
• Experience in rare disease, hematology, or bleeding disorders preferred
• 10+ years in a management or functional leadership role
• Demonstrated ability to identify and implement operational process improvements
• Proven track record of on-time, on-budget trial delivery in complex global programs
• Excellent cross-functional collaboration and executive communication skills
• Deep expertise in early and late-phase trial design and execution
• Experience managing and optimizing CRO and vendor relationships
• Recognized as an influential and respected leader within the organization and…