PK/PD Modeling Scientist — Biotech Drug Development

Join Hemab, a clinical-stage biotech company, on an exciting journey to build the ultimate clotting company. We focus on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Cambridge, MA, USA, and Copenhagen, Denmark, Hemab cultivates a vibrant, agile and forward-thinking environment where collaboration, innovation, and high-quality biotherapeutics development go hand in hand. As a Scientist, PK/PD Modeling & Simulation, you will be responsible for developing, validating, and applying population PK, PK/PD, exposure–response and QSP models to support model-informed drug development across Hemab’s pipeline. You will work closely with internal cross-functional leads (clinical pharmacology, nonclinical, clinical development, biometrics, regulatory and quality) and external collaborators (CROs and consultants) to provide quantitative insights that inform dose selection, clinical study design, and regulatory filings. Your work will be central to integrating modeling and simulation strategies into Hemab’s clinical programs and advancing our mission to deliver first-in-class therapies to patients with rare bleeding disorders. At Hemab, we foster an environment where everyone can wear multiple hats depending on their experience, fit, and motivation to get things done. We constantly strive to celebrate our achievements collectively and gather feedback to continuously sustain and improve our fast-paced, cross-functional work environment. What you'll do at Hemab? Develop, validate, and execute population PK, PK/PD exposure–response, PBPK and QSP models to support dose selection, regimen optimization, and trial design. Perform simulations to inform early clinical study design, establish clinical proof-of-concept (PoC), and guide pivotal program decisions. Analyze preclinical and clinical PK/PD data, translating insights into actionable recommendations for clinical teams. Contribute quantitative components for regulatory submissions (INDs, CTAs, BLAs) and respond to agency questions on modeling and simulation deliverables. Collaborate cross-functionally to ensure modeling insights are integrated into development plans and communicated clearly to stakeholders. Stay current with regulatory expectations, industry trends, and new quantitative methods to continuously improve modeling strategies and workflows. Support vendor and consultant selection and management to ensure high-quality, timely deliverables for modeling and simulation activities. Be a proactive and collaborative team player, receptive to constructive feedback and committed to meeting program goals. Who You Are and What You'll Bring to Hemab? Education: Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Applied Mathematics, Statistics, or related field; with 1–3 years of relevant experience. Experience: Hands-on experience with population PK/PD modeling software (NONMEM, Monolix, Phoenix NLME) and programming languages (R, MATLAB). Strong understanding of PK/PD principles, biologics drug development, and model-informed drug development strategies. Experience in one or more of the following areas is preferred: biologics PK/PD, rare disease development, translational modeling, or target-mediated drug disposition (TMDD). Familiarity with quantitative systems pharmacology (QSP) approaches is a plus. Demonstrated ability to analyze, interpret, and communicate complex quantitative data to diverse audiences, including cross-functional teams and regulatory authorities. Experience contributing to or supporting regulatory submissions is desirable. Excellent problem-solving skills, scientific curiosity, and the ability to thrive in a collaborative, fast-paced biotech environment. Apply for the position Scientist, Quantitative Clinical Pharmacology (PK/PD Modeling & Simulation) #J-18808-Ljbffr Hemab ApS