An innovative, publicly traded biotech company is recruiting a DMPK Scientist to be based in Boston, USA. The company is focused on translating the science of siRNA into human therapies.
The DMPK Scientist role will be involved in the design, execution, analysis, interpretation and communication of PK/ADME studies of siRNA and their associated delivery system to provide PK/ADME characteristics to support drug development from preclinical through clinical development. This position will require knowledge of PK/PD modeling to facilitate prediction of exposure required in humans.
- Represent DMPK as the subject matter expert for preclinical and clinical DMPK matters to Company project teams
- Responsible for the analysis, interpretation, integration and reporting of preclinical and clinical DMPK data generated both internally and with external vendors/academic sites
- Review and interpret bioanalytic data and reports.
- Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo ADME and DMPK modeling studies.
- Lead and prepare DMPK components of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures.
- Prepare strategic and scientifically sophisticated DMPK drug development strategies that meet regulatory requirements and program goals.
- Author high quality Regulatory documents including INDs, CTAs and NDA filings.
- Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments.
- Participate in the preparation of abstracts and manuscripts for publication
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 0-5 years experience in the biopharmaceutical industry, with evidence of drug development experience.
- Strong knowledge of ADME concepts, pharmacokinetic modeling, pharmacodynamic and bioanalytical principles. Proficient in standard MS software (Word, Excel and Power Point) and experience using WinNonlin or other pharmacokinetic software. Experience in RNAi technology a plus.
- Strong communication skills (verbal and written) and presentation skills required. Excellent interpersonal skills and ability to represent DMPK in a team environment are essential. Travel may occasionally be required.
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 Matt Tong on +1 646 768 9726 or upload your CV 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.