Director, DMPK Modeling and Simulations - Boston
About Frontier Medicines
Frontier Medicines, located in South San Francisco, CA and Boston, MA, is a precision medicine company that has pioneered a powerful discovery and development platform designed to generate medicines against disease-causing proteins previously considered undruggable. We are deploying our technologies in chemoproteomics, covalent drug discovery, and machine learning to develop a pipeline of groundbreaking medicines against the most important drivers of disease. Frontier has been recognized as a Fierce 15 company and a C&EN Start-Up to Watch. Our lead program targets both the active and inactive forms of KRASG12C, a validated driver in a number of cancers that until recently has been undruggable. Our pipeline embodies our vision of boldly advancing science to defeat disease, starting with cancer.
About the Role
Frontier Medicines is currently seeking a Director, DMPK Modeling & Simulations (M&S) who will report to the Head of DMPK. This highly motivated and skilled leader will be responsible for determining, planning, and executing M&S analyses for Frontier Medicines drug development programs and be an integral player in a highly multidisciplinary and cross-functional team. The Director, DMPK Modeling & Simulations (M&S) will provide strategic and hands-on PK, PKPD, QSP (quantitative systems pharmacology) and PBPK (Physiologically-based Pharmacokinetics) modeling support for Frontier’s rapidly evolving preclinical Oncology pipeline. The qualified candidate will serve as the lead and expert for diverse DMPK modeling challenges in research and development, with an initial emphasis on preclinical modeling.
Frontier is quickly growing from discovery into preclinical and clinical project stages. DMPK and Modeling and Simulation play a pivotal role in risk assessment/mitigation of Frontier’s chemical equity, and will be instrumental in defining the path forward for our projects. This role will operate at the interface of DMPK with Chemistry, Pharmacology, Safety, and Formulation. It is a fantastic opportunity to set integrated Modeling and Simulation strategy in alignment with our DMPK and Clinical Pharmacology vision, and contribute broadly and deeply across all active phases of drug discovery and development.
Together, we will deliver differentiated medicines that have real impact on people’s lives.
- Advance DMPK M&S strategy for Frontier’s projects and platform.
- Design, develop, and qualify modeling approaches supporting all stages of Frontier’s project portfolio: Elucidation of PK/PD/Biomarker/Efficacy relationship leveraging mechanistic or fit-for-purpose empirical models. Based on preclinical data, drive prediction of human PK, formulation impact, drug distribution/disposition, and human dose.
- Leverage modeling insights to advise on early prediction of translational biomarker strategies, and drug/drug interactions.
- Apply his/her expertise and training to establish quantitative and mechanistic understanding of preclinical and predicted human pharmacokinetic/pharmacodynamic relationships, culminating in predicting human PK and dosing, and will support identification of early clinical pharmacology considerations.
- Strong PK and ADME expertise for effective contextualization of modeling and simulation strategy and inputs/outputs.
- Effective communication of results to diverse internal and external stakeholders, including drafting of M&S contributions to regulatory documents.
- The candidate may serve as a DMPK core project representative.
- PhD (or equivalent degree) in Chemical Engineering, Pharmaceutical Sciences, or related discipline with 10+ years of relevant post-graduate experience in the Pharma or Biotech is preferred
- Proven track record of achievement in DMPK M&S.
- Deep hands-on experience with DMPK modeling and simulation software platforms, in particular Phoenix and GastroPlus or SimCYP. Proficiency of MATLAB, R, NONMEM or comparable applications highly desirable.
- Broad understanding of phys. chem. and PK/ADME properties of small molecules, pharmacological mechanism of action, and PD/efficacy biomarkers.
- Deep understanding of preclinical modeling principles, trends, and regulatory expectations of modeling and simulation data. Previous exposure to clinical modeling is desirable.
- Robust statistics/applied mathematics/computer science knowledge.
- Ability to effectively operate across diverse stakeholders in an energetic, fast-paced R&D environment.
- Excellent leadership competencies – collaboration, authenticity, impact, courage!