Bioanlytical, Scientist
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About The Position
Orum Therapeutics is seeking a highly motivated and accomplished scientist to lead the Bioanalytical and PK/PD function. The successful candidate will have extensive experience in bioanalytical and PK/PD method development and validation, quantitative and qualitative sample analysis, and data interpretation with a particular focus on small molecules and biologics. In this role, you will oversee technical monitoring throughout the bioanalytical method development, validation, and sample analysis processes, whether performed in-house or through external vendors. You will be responsible for managing method transfers between CROs, reviewing validation reports, and ensuring adherence to GLP/GCP regulations. Additionally, you will be accountable for analyzing pharmacokinetic (PK) data and generating PK/PD predictions to support the progression of our projects. The principal duties and responsibilities include overseeing all bioanalytical needs, whether in-house or through external vendors, to support DMPK and PK/PD studies. You will advise on analytical methods for measuring and quantifying small molecule transformations, manage metabolism, drug-drug interaction (DDI), and transporter studies at CROs, and conduct site visits, inspections, and SOP reviews to ensure compliance with regulatory standards and internal protocols. You will also review and approve validation reports, experimental bioanalytical documentation, and archive relevant study documents in consultation with the clinical team. Furthermore, you will integrate drug metabolism and pharmacokinetics (DMPK) predictions into bioanalytical workflows to support early-phase drug development and optimization, utilize modeling and simulation tools for human PK/PD predictions, and collaborate with and support other disciplines across the R&D organization while preparing regulatory documents as needed. Maintaining up-to-date knowledge of relevant scientific literature, regulatory guidance, and best practices is also essential.
