Job Summary:
We are seeking an experienced and driven Senior PK/PD Modeller to join our Clinical Pharmacology team. In this role, you will be responsible for the design, development, and implementation of pharmacokinetic/pharmacodynamic (PK/PD) modeling strategies to support drug development across all phases. You will collaborate cross-functionally with pharmacometrics, clinical, regulatory, and nonclinical teams to provide quantitative insight into drug behavior and inform key decision-making.
Key Responsibilities:
* Lead the development and execution of PK/PD modeling and simulation strategies for preclinical and clinical programs.
* Perform population pharmacokinetics (PopPK), exposure-response (E-R), and physiologically-based pharmacokinetic (PBPK) modeling.
* Translate complex quantitative data into actionable insights for dose selection, trial design, and regulatory interactions.
* Author or contribute to clinical study protocols, pharmacometric analysis plans, and regulatory submissions (IND, NDA, BLA, MAA, etc.).
* Serve as subject matter expert in modeling approaches and mentor junior scientists in PK/PD methodologies.
* Collaborate with biostatistics, clinical pharmacology, regulatory affairs, and other key stakeholders to integrate modeling insights into overall development strategy.
* Maintain awareness of new scientific and regulatory developments in pharmacometrics and contribute to external publications and presentations when appropriate.
Qualifications:
* PhD in Pharmaceutical Sciences, Pharmacology, Applied Mathematics, Biomedical Engineering, or related field; or PharmD/MSc with significant modeling experience.
* Minimum of 5–8 years of hands-on experience in PK/PD modeling, preferably within the pharmaceutical or biotechnology industry.
* Proficiency in NONMEM, Monolix, R, Phoenix WinNonlin, MATLAB, or other relevant software tools.
* Strong understanding of regulatory guidance and expectations related to modeling and simulation (e.g., FDA, EMA).
* Demonstrated ability to interpret and communicate complex data effectively to both technical and non-technical stakeholders.
* Track record of contributions to regulatory filings and/or scientific publications.
* Strong analytical, organizational, and project management skills.
Preferred Skills:
* Experience in mechanistic modeling or QSP (Quantitative Systems Pharmacology).
* Familiarity with PBPK modeling platforms (e.g., Simcyp, GastroPlus).
* Experience in oncology, CNS, immunology, or other specific therapeutic areas is a plus.
* Leadership in cross-functional project teams.
Why Join Us?
You’ll be part of a collaborative and innovative environment where your expertise will directly impact the development of transformative therapies. We offer a competitive salary, comprehensive benefits, flexible work arrangements, and the opportunity to grow professionally in a science-driven organization.