Jobs · Analyst · Indiana

Scientist/Senior Scientist – Oligonucleotides ADME/PK & Bioanalytics

The RNA Society · Indiana, United States · 2 wk ago
AnalystFull-time

Key Responsibilities

  • Design, execute, and interpret PK studies for different oligonucleotides in rodent and non-rodent models.
  • Characterize absorption, tissue distribution, metabolism, and excretion (ADME) of oligonucleotides with emphasis on both hepatic and extrahepatic tissue exposure (e.g., muscle, adipose tissue) where relevant;
  • Establish in vitro and/or ex vivo assays to assess molecule’s stability, protein binding, and metabolite profiling as needed;
  • Link molecule exposure (PK) to pharmacodynamic (PD) effects (e.g., target knockdown, steric blocking, pharmacological response);
  • Design and interpret single- and repeat-dose PK studies to support dose selection, regimen optimization, and translational modeling;
  • Lead and be accountable for preclinical proof-of-concept (POC) for targeted oligonucleotide platforms (e.g., antibody-oligonucleotide conjugates/AOCs) for extrahepatic delivery (e.g., muscle, adipose tissue);
  • Develop, validate, and implement robust bioanalytical assays for oligonucleotide quantification in plasma and tissues (e.g., qPCR-based assays, SL-RT-PCR, Hybridization ELISA, LC-MS/MS);
  • Ensure assays are fit-for-purpose with appropriate sensitivity, specificity, and dynamic range, particularly for low-abundance tissues;
  • Support biomarker strategies (e.g., target mRNA knockdown, protein modulation);
  • Ensure regulatory alignment (GLP where applicable).

Cross-functional & Project Leadership

  • Provide scientific and project leadership for ADME/PK components of oligonucleotide programs, particularly those focused on extrahepatic delivery;
  • Partner closely with discovery biology, oligonucleotide chemistry, and bioconjugation scientists;
  • Contribute to IND-enabling studies and regulatory documentation;
  • Oversee external CRO studies, ensuring scientific quality, timelines, and strategic alignment.

Qualifications & Experience

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Molecular Biology, or related field.
  • A minimum of +4 (Scientist) or +8 (Senior Scientist) years of hands-on experience in preclinical development of oligonucleotide therapeutics.
  • Demonstrated expertise in PK study design and analysis, Tissue biodistribution, including extrahepatic tissues, and Bioanalytical platforms (qPCR, LC-MS/MS, hybridization assays).
  • Hands-on experience leading or contributing to in vivo evaluation of targeted oligonucleotides (e.g., AOCs) with demonstrated success in POC for extrahepatic delivery (e.g., Skeletal muscle, adipose tissue).
  • Experience integrating biodistribution, PK/PD, and functional outcomesto drive candidate selection.
  • Demonstrated experience in project leadership or scientific ownership within cross-functional teams.
  • Experience establishing capabilities and working with CRO partners.
  • Strong analytical rigor and data-driven decision-making.
  • Effective communicator with the ability to influence cross-functional stakeholders.

Similar jobs