Summary
Hemab is a clinical-stage biotech company focused on addressing the high unmet needs of patients with rare bleeding and thrombotic disorders. With offices in Cambridge, MA and Copenhagen, Denmark, Hemab offers a collaborative, agile, and science-driven environment dedicated to developing high-quality biotherapeutics.
We are seeking a Director – Quantitative Clinical Pharmacology to join our QCP team and provide hands-on leadership in PK/PD modeling and simulation across Hemab’s development programs. This role is ideal for an experienced quantitative scientist who enjoys deep technical work, scientific problem-solving, and close partnership with clinical and regulatory teams to enable model-informed drug development.
Location: Flexible within the U.S. | Remote eligible
What You’ll Do at Hemab
• Lead the design, development, and application of population PK, PK/PD, and exposure–response models to inform dose selection, regimen optimization, and clinical trial design.
• Drive model-informed drug development (MIDD) strategies across programs from early clinical development through late-stage decision making.
• Perform simulations to support first-in-human studies, proof-of-concept, and pivotal program decisions.
• Analyze and integrate preclinical and clinical PK/PD data, translating quantitative insights into clear recommendations for development teams.
• Serve as a key quantitative thought partner to clinical development, clinical pharmacology, biometrics, and regulatory colleagues.
• Author, review, and contribute to quantitative sections of regulatory submissions (INDs, CTAs, BLAs) and support health authority interactions related to modeling and simulation.
• Provide technical oversight and critical review of modeling deliverables generated by external vendors, CROs, and consultants.
• Help shape QCP best practices, standards, and scientific rigor across Hemab’s portfolio.
• Stay current with evolving regulatory guidance, quantitative methodologies, and industry best practices to continuously strengthen modeling approaches.
Who You Are
• Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Applied Mathematics, Statistics, or related discipline; or M.S. with substantial relevant industry experience.
• Significant hands-on experience in population PK/PD modeling and simulation within a biotech or pharmaceutical development environment.
• Deep expertise in NONMEM, Monolix, Phoenix NLME, and quantitative programming tools (e.g., R).
• Strong understanding of biologics development and translational PK/PD principles; rare disease experience is a plus.
• Demonstrated experience contributing to regulatory submissions and interactions involving modeling and simulation.
• Ability to clearly communicate complex quantitative concepts to non-quantitative stakeholders.
• Thrives in a fast-paced, collaborative biotech environment with a hands-on, ownership mindset.
Why This Role Stands Out
• Director-level technical ownership without people-management burden
• High scientific visibility and real influence on development decisions
• Opportunity to shape modeling strategy in a rare disease biotech
• Flexible, remote-friendly U.S. role