Senior Director of Clinical Operations - HMB-002 program

Hemab Therapeutics; Indiana; Ibrido; USD 210.000 - 320.000; Tempo pieno

Descrizione del lavoro

Hemab Therapeutics seeks a Senior Director of Clinical Operations to lead the operational engine behind the HMB-002 program, driving execution from first-in-human studies to pivotal trials. You will sit at the center of clinical strategy, owning end-to-end delivery and reporting to the VP Clinical Operations and CEO.

The role is Boston-based with hybrid in-office work 2–3 days per week, requiring a strategic, high-impact leader who can raise the bar on execution and create patient-centric,

Competenze

• Bachelor's degree or higher in life sciences, biology, or related field.
• 15+ years of clinical operations/clinical program management experience in pharmaceutical or biotech.
• 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.

Mansioni

• Drive end-to-end operational delivery across a growing global portfolio from first-in-human studies to pivotal trials.
• Own end-to-end operational execution of clinical trials from protocol finalization through clinical study report; ensure delivery on time, within budget, and to the highest quality standards.
• Lead budget ownership across the program including forecasting, tracking, and actively managing spend to ensure financial discipline.
• Build and evolve processes, standards, and SOPs that scale with the organization.
• Establish data-driven reporting to keep leadership and teams informed on trial status, risks, and performance.

Conoscenze

ICH/GCP knowledge

Leadership experience

Trial design

Regulatory submissions

Cross-functional collaboration

Executive communication

Global program delivery

Life sciences intuition

Formazione

Bachelor's degree or higher in life sciences

Descrizione del lavoro

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.

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

• 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

Required

QUALIFICATIONS & EXPERIENCE

• 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.