We are looking for a Pharmacometrician who is passionate about their profession and inspired by being part of a team, working in life sciences, to bring a therapy to patients. This is an opportunity to make an impact while being part of a historically significant company that is making a difference to the lives of millions of people.
Reporting to the Head of Translational Data Sciences and Advanced Analytics will be responsible for translational modelling, population PK, PKPD, exposure-response, PBPK, disease modelling, and simulations in all clinical development phases. Apply state-of-the-art modelling and simulation (M&S) approaches to influence designs. The successful candidate will possess an understanding of pharmacometrics, pharmacokinetics, PK/PD, PBPK and modeling concepts and applications.
- Accountable for expert data integration, analysis, interpretation, and reporting of M&S results at the project level
- Accountable for executing state-of-the-art M&S techniques with direct value for the project
- Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Contribute to regulatory documents and interactions (oral/written)
- Presentation of M&S results in internal and external forum
- Contribute to internal initiatives to develop the pharmacometric discipline including its processes
- Contribute to or conduct population PK, PK/PD and PBPK modeling and simulation projects using industry standard software tools, including model development, validation, and refinement
- Work with other scientists to prepare and review population PK reports and other clinical pharmacology documents.
- Assist with development and validation of programming code in relevant software for PK, PK/PD, PBPK, and population PK analyses
- Author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
- Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize PK sampling and dosing strategies
- M.S. or Ph.D. in pharmacometrics, pharmacokinetics, pharmaceutical sciences, pharmacology, biostatistics, or similar disciplines where modeling and simulation is emphasized
- 3+ years of industry experience in practical applications of modeling and simulation required
- Significant demonstrated expertise within the field of M&S, including PK, PKPD, PBPK and statistics
- Demonstrated ability to identify, develop and execute strategic M&S activities at the project level
- A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to pharmacometrics
- Expert knowledge of pharmacokinetics and Model-Based Drug Development (T)
- Demonstrated broad translational and clinical development expertise and experience in drug development, with emphasis on Pharmacometrics.
- Excellent oral and written communication skills
- Relevant regulatory experience (written/oral)
- Training and experience with Pharmacomterics and statistical software (NONMEM,R, Stan, Winbugs ,SAS, Monolix , Phoenix, WinNonlin, Matlab, PKSim, Gastroplus, SimCYP)
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AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.