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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sofia Amark at (+1) 646-367-2764 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.