Senior Director, Clinical Operations — Hybrid Global Trials

HiTalento TALENTO ApS

Boston (MA)

Hybrid

USD 180,000 - 300,000

Full time

16 hours ago
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Job summary

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, from first-in-human studies to pivotal trials. You will sit at the center of Hemab's clinical strategy and execution, owning end-to-end delivery across a growing global portfolio, while reporting to the VP Clinical Operations and CEO.

Boston-based, hybrid with a min of 2-3 days in office, the role requires building robust partnerships,

Qualifications

  • 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.
  • Recognized as an influential and respected leader within the organization and industry.

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.
  • 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.

Skills

ICH/GCP expertise
Regulatory knowledge
Trial delivery leadership
Cross-functional leadership
Vendor management
Executive communication

Education

Bachelor's degree or higher in life sciences

Job description

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, from first-in-human studies to pivotal trials. You will sit at the center of Hemab's clinical strategy and execution, owning end-to-end delivery across a growing global portfolio, while reporting to the VP Clinical Operations and CEO.

Boston-based, hybrid with a min of 2-3 days in office, the role requires building robust partnerships,

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