Senior Director of Clinical Operations - sutacimig program

We need to output HTML fragment with sections: About the role (already present), Key Responsibilities (maybe split into sub-sections? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need headings for each section that has content. We have "About The Role" content. Then responsibilities: there is a block "Key Responsibilities" with sub-bullets. Then there are sections: Innovation & Continuous Improvement, Vendor & Site Management, Regulatory Quality & Compliance, Leadership & Cross-Functional Collaboration. Those could be considered sub-sections under Responsibilities or separate sections. The instruction: "Prefer a few substantive sections over many thin ones." So maybe combine those into a single Responsibilities section with sub-bullets? But they are distinct categories; we could keep them as subheadings? However only allowed headings are h3 for section headings; we could use h3 for each major section: About the role, Responsibilities, Innovation & Continuous Improvement, Vendor & Site Management, Regulatory Quality & Compliance, Leadership & Cross-Functional Collaboration, Qualifications, Skills? Actually we have Required QUALIFICATIONS & EXPERIENCE and Preferred Experience. Could combine into Qualifications section. Skills maybe not explicit. Benefits, Pay, Schedule not present, so omit. We must not repeat job title as heading. Already not. We must not include Job ID etc. We must remove boilerplate: equal opportunity employer line etc. Also "Hemab Therapeutics, Inc. | Senior Director, Clinical Operations | Hemab Therapeutics is an equal opportunity employer..." remove. We need to preserve all substantive info. Let's extract content: About The Role paragraph: "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: list of bullet points under "Operational Excellence & Study Delivery", then "Innovation & Continuous Improvement", "Vendor & Site Management", "Regulatory Quality & Compliance", "Leadership & Cross-Functional Collaboration". Each has multiple bullet points. We need to output

• for any list of duties/requirements/benefits. So each bullet becomes
• . Could group under headings? The instruction: use

  for section headings. Could have

  Responsibilities

  then
  with all responsibility bullets. But we also have subcategories; maybe we keep them as separate headings under Responsibilities? But that would be many thin sections. Could combine all responsibility bullets into one list under a single Responsibilities heading. That would preserve all info but lose categorization. However the instruction says prefer a few substantive sections over many thin ones. So better to have one Responsibilities section with all bullets. Similarly, Qualifications: we have Required QUALIFICATIONS & EXPERIENCE block and Preferred Experience. Could combine into Qualifications section with two sub-lists? But we could just list all qualifications as bullets under Qualifications heading. That would be fine. We must not invent or summarize away detail. So we need to keep each bullet exactly as in text. Let's extract bullets: 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 Now Qualifications: 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: - 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 Now About Hemab Therapeutics paragraph: "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." We could put this under a section "About the Company" but not in allowed headings list. The allowed headings list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. There's no "About the Company". However we could incorporate that into About the role? The About the role section already has description; we could add the company description there as part of About the role. The instruction: "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., not exclusive. So we could add other headings if needed, but better to stick to those. The company description could be placed under About the role as additional prose. That seems okay. Thus final HTML:

  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. 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.

  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 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