DMPK Principal Scientist, M&S Modeler
We are currently seeking a highly skilled and motivated individual to provide quantitative modeling guidance and perform hands-on Quantitative systems pharmacology (QSP), PKPD and PBPK modeling for research and development programs at Vertex.
In this role the qualified candidate will act as a lead preclinical PKPD modeling expert in interdisciplinary teams to support the drug discovery and development process by applying his/her knowledge and technical expertise to quantitatively characterize the pharmacokinetics, pharmacodynamics, and biomarker (PK/PD/Biomarker) properties of drug candidates. Quantitative understanding of the target and degree of modulation required for disease progression modification is necessary for setting human target exposure and desirable PK profiles. A thorough understanding of the biology, mechanism of action, efficacy biomarker and DMPK properties is essential for this individual to build mechanism-based mathematical models and update such models to incorporate new information throughout the lifespan of the projects. In addition, his/her core responsibilities also include PBPK modeling to integrate preclinical in vitro data for absorption and drug-drug interaction predictions. Prior experience with regulatory submissions of such PBPK DDI modeling work is highly desirable. The candidate may serve as a project team representative for discovery and development projects.
Key Duties and Responsibilities:
- Develop/code and validate mathematical PK/PD/Biomarker/Efficacy models to elucidate the quantitative PK/PD relationships in pre-clinical species.
- Perform advanced troubleshooting for the related mathematical models independently.
- Work with Clinical Pharmacology to assess the clinical potential for drug-to-drug interactions using physiology-based PK (PBPK) modeling tools (e.g., SimCYP).
- Apply expertise in drug metabolism and pharmacokinetics (DMPK) principles and translational QP and PKPD methodologies as studies move from preclinical to clinical phases.
- Draft PBPK reports in support of regulatory submissions.
- Demonstrate an astute understanding of the PKPD and QSP field and the relevant literature.
- Utilize pre-clinical data for human efficacious dose prediction.
- Prepare peer-directed presentations for the internal scientific communit
Education and Experience:
- Ph.D. (or equivalent degree) in Chemical Engineering, Pharmaceutical Sciences, or related discipline with 4+ years of related experience
- PKPD modeling software, such as MATLAB, Phoenix, ADAPT and NONMEM
- PBPK modeling software, such as Gastroplus, SimCYP
- Basic programming language: R, Python, etc.
- Prior DMPK team lead experience
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.