Scientist, Quantitative Clinical Pharmacology (PK/PD Modeling & Simulation)

About the role

Join Hemab, a clinical-stage biotech company focused on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. Based in Cambridge, MA, USA, and Copenhagen, Denmark, Hemab fosters a vibrant, agile, and forward-thinking environment where collaboration, innovation, and high-quality biotherapeutics development go hand in hand.

Responsibilities

• Develop, validate, and execute population PK/PD, exposure–response, 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.
• 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.

Requirements

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.