Senior Principal Scientist | Antibody-siRNA Bioanalytical & Biodistribution Strategy Lead

Role Summary

Senior Principal Scientist - Antibody-siRNA Bioanalytical & Biodistribution Strategy Lead. Lead the strategy and execution of innovative bioanalytical platforms to measure antibody-siRNA conjugates in preclinical samples (in vitro and in vivo) to characterize ADME and understand pharmacokinetics and PK-PD relationships. Represent PKDM-BA on project teams and collaborate with cross-functional teams to drive clinical candidate selection and regulatory filings.

Responsibilities

• Lead strategy to establish innovative bioanalytical platforms to measure antibody-siRNA conjugates in preclinical samples (in vitro and in vivo)
• Lead strategy to establish innovative in vitro ADME assays for antibody-siRNA conjugates
• Design, execute, and interpret results from in vivo studies characterizing pharmacokinetics, PK-PD relationships, tissue distribution, and toxicokinetics of antibody-siRNA conjugates
• Serve as PKDM-BA project team representative for antibody-siRNA conjugates and other siRNA modalities
• Lead and execute the preparation of pharmacokinetic written summaries for regulatory applications
• Mentor and cross-train PKDM-BA scientific colleagues
• Foster cross-functional collaboration across Research and Development to advance siRNA therapeutics from discovery to clinical proof of concept

Qualifications

• Required: Doctorate in pharmacology, biochemistry or related scientific discipline and 3 years of industry experience; or Master’s degree with 6 years of industry experience; or Bachelor’s degree with 8 years of industry experience
• Preferred: Extensive knowledge of antibody-siRNA conjugate ADME and pharmacokinetics; experience with other siRNA modalities, antibody-drug conjugates, peptide conjugates, biologics and/or small molecules
• Preferred: Experience investigating biodistribution and metabolism of siRNA conjugated to a tissue-targeting ligand
• Preferred: Expertise in antibody-siRNA bioanalytical approaches and considerations
• Preferred: Extensive experience with ligand binding assays (immunoassay and hybridization assays) and LC/MS bioanalytical platforms; RT-qPCR and/or RT-ddPCR experience
• Preferred: Exceptional written and verbal communication skills
• Preferred: Experience with regulatory filings for antibody-siRNA conjugates and/or other targeted delivery siRNA therapeutics

Education

• Doctorate in pharmacology, biochemistry or related scientific discipline (or equivalent) with applicable post-doctoral experience
• Alternative: Master’s degree in pharmacology, biochemistry or related discipline with substantial industry experience
• Alternative: Bachelor’s degree in pharmacology, biochemistry or related discipline with substantial industry experience