QSP Modeling Lead, Oncology R&D, Orion Corporation

Orion Pharma • Boston, MA

2h • $130,000 - $230,000 • Hybrid

About The Position

The role of QSP Modeling Lead will be responsible for generating and implementing mechanistic pharmacology models to support drug development at all stages, from preclinical research to clinical trials and beyond, aiding in dose optimization, biomarker identification, safety and efficacy assessment, and drug development decision-making, leveraging integrated non-clinical and clinical data. The successful candidate will serve as a scientific and strategic leader, partnering cross‑functionally with in Translational Pharmacology, DMPK, Pharmacometrics, Clinical Biomarkers, Bioinformaticians, Research, and Clinical Development to ensure model‑informed decision making across the portfolio. The incumbent will be responsible for quantitative systems pharmacology (QSP) modeling executed internally or in collaboration with external CROs and will provide close scientific and technical supervision. The incumbent will also be expected to independently manage multiple projects simultaneously and participate in discussions and presentations.

Requirements

• PhD in Pharmacology, Biomedical/Chemical Engineering, Biology, Systems Biology, Applied Mathematics, or a related quantitative discipline.
• Industry relevant experience in QSP modeling and application of MIDD principles in a drug-development setting
• Extensive experience with exploratory data analysis, modeling and simulation with e.g. Python or R is required.

Nice To Haves

• Excellent knowledge of the theory and principles of Quantitative Systems Pharmacology plus hands-on competence in mathematical modeling of pharmacologic effects with mechanism-based models using relevant software or programming languages (e.g., MATLAB/SimBiology, Monolix,R).
• Solid knowledge of basic principles of biology and pharmacology at the organismal, cellular and molecular level, preferably in oncology.
• Ability to rapidly assimilate knowledge of complex biology of drug action for novel mechanisms and transform such understanding into multi-scale mathematical models, with requisite mathematical and computational proficiency
• Ability to work independently and deliver results in a timely manner

Responsibilities

• Lead the design, development, validation, and application of QSP models that will inform compound progression decisions from lead optimization to clinical proof of concept and beyond for the oncology pipelines for all modalities of interest.
• Integrate non-clinical PK/PD, efficacy, and biomarker data with emerging clinical PK/PD and biomarker data to inform human dose optimization, biomarker identification, safety and efficacy assessment, and drug development decision-making.
• Drive model‑informed drug development (MIDD) strategies across programs, influencing key development and portfolio decisions.
• Partner closely with Clinical Pharmacology and Translational Medicine Lead to ensure alignment between pharmacology modeling, bioanalytical strategies, and clinical endpoints.
• To be able to interact with various project team members in a clear and timely manner, understanding the functions of other team members and being able to explain and educate model-based analyses and results to team members from various backgrounds
• Work in a dynamic team with frequent interactions, both within the team and with associated functions, and will be responsible for the development and implementation of innovative modeling and simulation platforms/strategy that ensure that the right drug is administered to the right patient at the right dosage.
• The candidate will contribute to the preparation and presentation of both internal and external documentation (e.g. Investigator’s Brochure, IND, CTD) and program strategy.

Benefits

• Your work impacts millions of lives around the world.
• Work on challenges that matter and see the difference your work makes every day.
• Investment in your continuous learning.
• Innovative products are world-class.
• Sustainability and ethics are taken seriously.
• Teamwork, low hierarchies, and a culture where every voice is heard.
• Jobs with a clear purpose: helping people live their lives to the fullest.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree