Bioanalytical Scientist

Orum Therapeutics is seeking a highly skilled Bioanalytical 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 focus on small molecules and biologics.

• Oversee all bioanalytical needs, whether in-house or through external vendors, to support DMPK and PK/PD studies.
• Advise on analytical methods for measuring and quantifying small molecule transformations.
• Conduct site visits, inspections, and SOP reviews to ensure compliance with regulatory standards and internal protocols.
• Review and approve validation reports, experimental bioanalytical documentation, and archive relevant study documents in consultation with the clinical team.
• 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, enabling dose projection or safety evaluation.
• Maintain up-to-date knowledge of relevant scientific literature, regulatory guidance, and best practices.

• Ph.D. or equivalent degree in Analytical chemistry or a related field with minimum 5 years' experience.
• Extensive experience with pharmacokinetic and biodistribution studies of antibody-drug conjugates and relevant analytical methods.
• Proven experience in developing and validating assays for antibody-drug conjugate modalities.
• Strong expertise in non-compartmental analysis of PK data, with demonstrated experience in PK-PD modeling and simulation.
• Good understanding of GLP/GCP regulations and their application in bioanalytical contexts.

Orum Therapeutics is an Equal Opportunity Employer (EOE) offering a competitive salary and benefits package.