Senior Director of Clinical Operations - sutacimig program Job at Life Science Talent (Boston)

Job Description

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.

Job Responsibility

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

Requirements

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
Registration (BLA/MAA) submission experience
Recognized as an influential and respected leader within the organization and industry

Nice to have

Experience in bleeding disorders: VWD, hemophilia A/B, Glanzmann thrombasthenia, or related hematologic conditions
Experience with clinical technology innovation, including decentralized or hybrid trial components

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Senior Director of Clinical Operations - sutacimig program

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