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.