Scientist, Quantitative Clinical Pharmacology (PK/PD Modeling & Simulation)
Hemab Therapeutics · Cambridge, MA · 3 days ago
On-siteScienceFull-time
About the role
We are seeking a Scientist, PK/PD Modeling & Simulation to join our dynamic team at Hemab. This position offers the opportunity to contribute to the development of innovative therapies for rare bleeding disorders.
Responsibilities
- Develop, validate, and apply population PK, PK/PD, exposure–response, and QSP models to support model-informed drug development across Hemab’s pipeline.
- 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.
- Contribute to the integration of modeling and simulation strategies into Hemab’s clinical programs and advance our mission to deliver first-in-class therapies to patients with rare bleeding disorders.
- Analyze preclinical and clinical PK/PD data, translating insights into actionable recommendations for clinical teams.
- Support vendor and consultant selection and management to ensure high-quality, timely deliverables for modeling and simulation activities.
- Collaborate cross-functionally to ensure modeling insights are integrated into development plans and communicated clearly to stakeholders.
Requirements
- Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Applied Mathematics, Statistics, or related field; with 1–3 years of relevant 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.