Principal Scientist - Dmpk

Client is seeking a Principal Scientist to serve as DMPK subject matter expert on multi-disciplinary project teams to advance our portfolio of novel analgesic programs. The candidate will develop and execute DMPK study plans for multiple projects at various stages of pre-clinical drug development (hit to lead, lead optimization, development candidate IND-enabling studies). The successful candidate will have a can-do attitude, be inquisitive with a passion for science, and demonstrate a willingness to continuously learn in a team environment.

Primary responsibilities include (but are not limited to):

• Represent DMPK functional area on preclinical project teams; present collated ADME data summarizing SAR trends and IVIVC to guide prioritization of compound selection for advancement in the flow scheme.
• Design and manage outsourced preclinical in vitro ADME studies and analyze/interpret data from these studies.
• Design and manage internal and outsourced in vivo PK studies in rodent and non-rodent species and analyze/interpret data from these studies.
• Perform early human dose-prediction modeling.
• Maintain database with ADME data across programs.
• Write/review ADME study reports and contribute to authoring of regulatory documents.

Basic qualifications:

PhD in Pharmacokinetics/Pharmaceutical Sciences/Biochemistry or a related scientific field with at least 10 years of direct DMPK project representation experience in biotech industry.

Preferred Qualifications:

• Demonstrated knowledge and experience in pharmacokinetics, pharmacodynamic, drug metabolism, and bioanalytical principles.
• Hands-on experience analyzing PK data and building PKPD relationships using relevant software programs such as phoenix/WinNonlin.
• Knowledge and experience with generating human dose projections based on allometry and/or IVIVC data.
• Experience in developing protocols and writing study reports and other relevant documents to support regulatory filings.
• Strong quantitative, analytical, and organizational skills.
• Excellent verbal and written communication skills.
• Experience working productively in a cross-functional, matrixed organization.