Director – Quantitative Clinical Pharmacology (PK/PD Modeling & Simulation)

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