Senior Director of Clinical Operations - sutacimig program

Senior Director of Clinical Operations - sutacimig program Hemab Cambridge, MA Job Details Contract $265,000 - $285,000 a year 1 day ago Qualifications Clinical program budget management Investigational new drug (IND) applications Supplier relationship improvement Schedule management ICH guidelines Bachelor's degree Pharmaceutical company experience Managing clinical research teams Vendor relationship management Leading team collaboration initiatives Data-driven problem-solving Communication with regulatory authorities for clinical trials Clinical team leadership Clinical quality assurance standards Process improvement planning Achieving project delivery timelines Cross-functional team management Program budgeting Cross-functional communication Senior leadership Full 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 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

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 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 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

QUALIFICATIONS & EXPERIENCE

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

ABOUT HEMAB THERAPEUTICS

Hemab 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.

Pay:

$265,000.00 - $285,000.00 per year

Work Location:

In person