Located in Boston, MA

Responsibilities of the Senior Scientist (DMPK):

• Ensure selection and utilization of appropriate in vitro and or in vivo methods and models to evaluate absorption, distribution, metabolism, excretion (ADME), and pharmacokinetic (PK)- related to oligonucleotide therapies.
• Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and with external vendors.
• Build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation for oligo therapeutics.
• Participate in the management of CROs in the conduct of in vitro/in vivo ADME studies.
• Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals.
• Author high-quality Regulatory documents including INDs and CTAs filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management, and other departments.

Requirements of the Senior Scientist (DMPK):

• MS or PhD in Pharmaceutical Sciences, Biochemistry, Chemistry, or a related field and 5+ years relevant experience.
• In-depth understanding in oligonucleotide bioanalysis, including LC-MS/MS, HRMS, and other platforms.
• Must have experience with WinNonlin and PK data analysis.
• Self-motivation, ability to work independently and excellent organization skills that enable multitasking and working within timelines is required.