Jobs · Massachusetts

Senior Scientist I, DMPK

Wave Life Sciences · Lexington, MA · 1 mo ago
Hybrid$157k/yrFull-time

About the role

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave Life Sciences is seeking a highly motivated and detail-oriented Scientist with strong expertise in bioanalytical and Drug Metabolism and Pharmacokinetics (DMPK) sciences to support drug development programs from preclinical through clinical stages. The successful candidate will play a key role in independently designing, executing, and interpreting pharmacokinetic (PK), toxicokinetic (TK), plasma protein binding and in vitro drug-drug interaction (DDI) studies.

Responsibilities

  • Independently design, execute, and interpret in vitro and in vivo studies (i.e., ADME, PK, PK/PD) to support advancement of RNA therapeutic programs
  • Autonomously analyze and interpret PK, TK and PK/PD data using appropriate software tools (e.g., Phoenix WinNonlin), including conducting NCA and graphical exposure-response analyses
  • Represent DMPK function at cross-functional project team meetings
  • With guidance, plan, execute, and deliver DMPK deliverables from lead selection to IND stage
  • Collaborate with cross-functional teams including bioanalysis, discovery research, toxicology, clinical pharmacology, regulatory, and external CROs to meet program goals and timelines
  • Prepare high-quality scientific reports and integrate DMPK data into regulatory documents (IND, CTA, briefing documents, etc.)
  • Manage internal and external (CRO) DMPK activities including DDI, PPB, to ensure timely delivery of high-quality data
  • Deliver robust IND/CTA-enabling DMPK packages to support regulatory filings
  • Stay current with regulatory guidance and scientific advances in the field of bioanalysis and DMPK

Requirements

Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, or related discipline with at least 3 years of relevant experience, or M.S. with at least 6 years of industry experience

The ideal candidate will have experience supporting the development of RNA-based modalities (e.g., siRNA, antisense oligonucleotides, GalNAc conjugates, etc.)

Key Skills

  • Proficient in PK software tools such as Phoenix WinNonlin and conduct NCA
  • Conduct graphical analysis using standard tools like Phoenix WinNonlin, R, or similar
  • Demonstrate sound knowledge of PK/PD principles
  • Familiarity with regulatory requirements

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