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Job Overview
Employment Type
Full-time
Compensation
Salary
Range $265,000.00 - $285,000.00
Work Schedule
Flexible
Benefits
Health Insurance
Paid Time Off
Dental Insurance
Vision Insurance
Retirement Plan
Life insurance
Disability insurance
Job Description
Hemab Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with rare and underserved bleeding disorders. Focused specifically on conditions such as Glanzmann thrombasthenia and von Willebrand Disease, Hemab addresses significant unmet medical needs by pioneering novel treatment options where innovation has historically been limited. As a lean, high-trust organization, Hemab emphasizes impact, excellence, and integrity in its pursuit of better patient outcomes. The company fosters a dynamic work environment characterized by agility, thoughtful decision-making, and high standards, all aimed at improving the lives of patients affected by these challenging disorders. Hemab Therapeutics values diversity and... Show More
Job Requirements
- 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
- strong command of ICH/GCP and international regulatory requirements
- 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
Job 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
- registration (BLA/MAA) submission experience
- recognized as an influential and respected leader within the organization and industry
- experience in bleeding disorders: VWD, hemophilia A/B, Glanzmann thrombasthenia, or related hematologic conditions preferred
- experience with clinical technology innovation, including decentralized or hybrid trial components preferred
Job Duties
- 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
Job Criteria
Experience
Expert Level (7+ years)
Job Location
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