Senior Director of Clinical Operations - sutacimig program

ABOUT THE ROLEHemab 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 officeKEY RESPONSIBILITIESOperational Excellence & Study DeliveryDrive innovative, creative and efficient trial design and optimizationAccountability 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 planOwn 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 standardsDrive rigorous planning and accountability across all functions: define milestones, manage risks proactively, and resolve operational issues with urgency and precisionBuild and evolve fit-for-purpose processes, standards, and operating procedures that scale with the organization and reflect industry best practiceEstablish and maintain transparent, data-driven reporting mechanisms to keep executive leadership and cross-functional teams fully informed on trial status, risks, and performance metricsLead budget ownership across the program including forecasting, tracking, and actively managing spend to ensure financial discipline without compromising quality or speedInnovation & Continuous ImprovementProactively 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 qualityApply lessons learned systematically across programs; lead a culture of retrospective analysis, iteration, and continuous improvementExplore and evaluate emerging industry trends, regulatory innovation pathways, and operational models to keep Hemab at the forefront of rare disease trial executionVendor & Site ManagementIdentify, select, and manage study partners and external consultants with high expectations for performance, accountability, and alignment with Hemab's standardsLead constructive, trust-based partnerships with investigative sites globally — ensuring clear plans, milestones, and open communication to maximize enrollment performance and data qualityDevelop and execute robust resourcing and oversight plans for clinical trials, including risk-adapted monitoring strategiesRegulatory Quality & ComplianceEnsure all trials are conducted in strict accordance with ICH/GCP requirements, applicable regulations, and Hemab's SOPs and quality standardsParticipate in the development of critical regulatory and study documents: protocols, ICFs, investigator brochures, clinical study reports, and INDs/CTAsLeadership & Cross-Functional CollaborationServe as a key functional leader and subject matter expert across the organization, effectively partnering to execute clinical studies and development strategyBuild, mentor, and inspire a high-performing clinical operations team; develop talent at all levels and cultivate a culture of excellence, accountability, and innovationActively shape departmental and corporate strategy, bringing operational insight and foresight to leadership discussionPromote collaboration and creativity within Clinical Operations to drive standardization, efficiency, cost management, and sustainable solutions for long-term clinical developmentJoin and represent the asset at board of directors meetings for updates and reviewsQUALIFICATIONS & EXPERIENCERequiredBachelor's degree or higher in life sciences, biology, or related fieldStrong command of ICH/GCP and international regulatory requirements15+ years of clinical operations/clinical program management experience in pharmaceutical or biotechExperience in rare disease, hematology, or bleeding disorders preferred10+ years in a management or functional leadership roleDemonstrated ability to identify and implement operational process improvementsProven track record of on-time, on-budget trial delivery in complex global programsExcellent cross-functional collaboration and executive communication skillsDeep expertise in early and late-phase trial design and executionExperience managing and optimizing CRO and vendor relationshipsRegistration (BLA/MAA) submission experienceRecognized as an influential and respected leader within the organization and industryPreferredExperience in bleeding disorders: VWD, hemophilia A/B, Glanzmann thrombasthenia, or related hematologic conditionsExperience with clinical technology innovation, including decentralized or hybrid trial componentsABOUT HEMAB THERAPEUTICSHemab Therapeutics is a clinical-stage biopharmaceutical company with a singular focus: developing transformative therapies for patients living with rare and underserved bleeding disorders. Our pipeline targets Glanzmann thrombasthenia, von Willebrand Disease, and other conditions that have long lacked meaningful treatment innovation.We are relentless in our pursuit of better outcomes for patients and equally relentless in how we build our organization. We hire people who are driven, intellectually curious, and deeply committed to doing this work with excellence and integrity.Hemab is a lean, high-trust organization where your work has direct, visible impact. We move fast, think carefully, and hold ourselves to a high standard because our patients deserve nothing less.Hemab Therapeutics, Inc. | Senior Director, Clinical Operations |Hemab Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.