Description:
Wave Life Sciences seeks a Scientist (hybrid; Lexington, MA) with expertise in bioanalytical and Drug Metabolism & Pharmacokinetics (DMPK) to support drug development from preclinical through clinical stages. You will independently design, execute, and interpret PK, TK, plasma protein binding, and in vitro drug-drug interaction (DDI) studies.
Experience/Qualifications:
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, or related with at least 3 years relevant experience; or M.S. with at least 6 years industry experience.
- Experience supporting development of RNA-based modalities (e.g., siRNA, antisense oligonucleotides, GalNAc conjugates).
Responsibilities:
- Independently design, execute, and interpret in vitro and in vivo ADME/PK/PK-PD studies for RNA therapeutic programs.
- Analyze/interpret PK, TK, and PK/PD data (e.g., Phoenix WinNonlin), including NCA and exposure-response analyses.
- Represent DMPK function at cross-functional project team meetings.
- Plan/execute/deliver DMPK deliverables from lead selection to IND stage.
- Collaborate with bioanalysis, discovery, toxicology, clinical pharmacology, regulatory, and external CROs.
- Prepare scientific reports and integrate DMPK data into IND/CTA/briefing documents.
- Manage internal/external DMPK activities (DDI, PPB) for timely, high-quality data.
- Deliver IND/CTA-enabling DMPK packages; stay current on regulatory guidance and scientific advances.
Key Skills:
- PK software (Phoenix WinNonlin) and NCA; graphical analysis (Phoenix WinNonlin, R, or similar).
- PK/PD knowledge; nonclinical DMPK regulatory familiarity.
- Expertise in plasma protein binding and in vitro DDI (CYP inhibition/induction, transporter interactions).
- Communication, organization, teamwork; bioanalysis knowledge (metabolite ID, biodistribution, etc.).
- Modeling/simulation experience is a plus.