Principal Scientist, DMPK

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Requirements:

• PhD in pharmacology or similar field with 8+ years of DMPK experience in an industry setting or a MS with 12+ years of relevant experience.
• Expertise with ADME studies and assays, with a proven track record of strategizing and troubleshooting based upon raw data.
• Vendor management experience, specifically managing CROs.
• Additional experience with other aspects of ADME, bioanalytical techniques, PK/PD, toxicokinetics, pre-clinical PK/PD modeling, and translational biology are strongly preferred.
• Experience with oligonucleotide-based modalities.
• Experience authoring and reviewing DMPK-related reports and regulatory documents for health authority submissions is highly desirable.
• Collaborative and strong communication skills.
• Ability to multi-task effectively and work within aggressive timelines.

Responsibilities:

• Lead all PK- and ADME-related efforts for designated program(s).
• Communicate and present relevant information across all areas of the organization, regardless of level.
• Select and manage PK/TK, PK/PD, and ADME CROs.
• Author and review PK/TK, PK/PD, and ADME reports.
• Author and review relevant PK/TK, PK/PD, and ADME sections of regulatory submission documents.
• Review associated reports, including clinical, toxicology, pharmacology, and bioanalysis.
• Collaborate with clinical teams, including pharmacology, biomarkers, development, and operations.
• Collaborate with non-clinical development teams, including toxicology and bioanalysis.
• Collaborate with discovery teams to guide future programs and better understand mechanisms of action.