Entradatherapeutics
Clinical Pharmacology Consultant
Boston, MA. Posted 25 days ago
The role
The Clinical Pharmacology Consultant will provide input to regulatory documents and participate in clinical study design. This person will lead the analysis and reporting of pharmacokinetic and pharmacodynamic data for assigned projects.
What you will do
- Provide clinical pharmacology input to regulatory documents
- Participate in clinical study design and documentation
- Lead and oversee the analysis, interpretation, integration and reporting of clinical pharmacokinetic and pharmacodynamic data
- Work collaboratively with Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory
- Monitor work with CROs and other external vendors
Required qualifications
- MS 8+ years in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or related discipline
- Ph.D. and 3 + years in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or related discipline
- Pharm.D. or M.D. with relevant experience
- Experience using Phoenix WinNonlin, R, NONMEM, MATLAB, or other pharmacokinetic and modeling software
- Strong mathematical model development and analytical skills
Nice to have
- Publication record with a demonstrated technical exposure to early exploratory trials through Phase 2/3 programs
- Compartmental PK/PD modeling experience
About the company
Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets. The company is advancing a development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases.