Clinical Pharmacology Scientist
Proclinical is currently recruiting for a Clinical Pharmacology Scientist with a biopharmaceutical company located in San Francisco, CA. Successful candidate will define and execute clinical pharmacology components of drug development programs, including planning, designing and oversight of studies
- Plan and execute clinical pharmacokinetic and pharmacodynamic analyses to support portfolio projects.
- Apply quantitative approaches to develop and implement translational PK/PD strategies, inform dose and dosing regimen selection and support product development decisions.
- Participate on and provide input to project teams.
- Contribute to regulatory documents (INDs, clinical trial documents including protocols and study reports, IBs, NDAs).
Skills and Requirements:
- Medical degree, PharmD or PhD (or equivalent) with at least 3-5 years' experience in pharmaceutical drug development.
- Good working knowledge of the drug discovery and development process.
- Background in pharmaceutical sciences, pharmacometrics, mathematics, (bio)statistics, biomedical engineering, or a related field.
- Demonstrated success in executing clinical pharmacology programs and quantitative drug development (population and mechanistic PK/PD modeling and simulations) through regulatory filings (IND, NDA/BLA, MAA).
- Scientific excellence as demonstrated through track record of publications or presentations in clinical pharmacology and application of quantitative methods in drug development.
- Proficiency in R, NONMEM, Phoenix WinNonlin, NLME, Matlab, SAS, or other similar applications.
- Experience in performing population PK and PK/PD analyses using pharmacometric software.
- Experience in experimental study design, problem solving, critical data analysis and interpretation.
- Scientific understanding of biopharmaceutics, ADME, and clinical pharmacology.
- Good written and verbal communication, interdisciplinary collaboration and problem solving skills and ability to work in a face paced environment.
If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.