Bioanalytical, Scientist

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. 

Principal Duties and Responsibilities 

• ​​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. Manage metabolism, drug-drug interaction (DDI), and transporter studies at CROs. 

• ​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.  

• ​Collaborate with and support other disciplines across the R&D organization and support regulatory document preparation as needed.  

• ​Maintain up-to-date knowledge of relevant scientific literature, regulatory guidance, and best practices.​ 

Skills, Abilities & Competencies 

• ​​Extensive experience with pharmacokinetic and biodistribution studies of antibody-drug conjugates and relevant analytical methods including LC-MS/MS for small molecule quantitation and MSD for ELISA and LBA-based assays. 

• ​Proven experience in developing and validating assays for antibody-drug conjugate modalities including total antibody, total and free payload, ADA, and NAb assays for ADC clinical PK samples. 

• ​Strong expertise in non-compartmental analysis of PK data, with demonstrated experience in PK-PD modeling and simulation, population PK, and meta-analysis (preferred). 

• ​Deep understanding of ADME processes and screening strategies from feasibility to candidate nomination.  

• ​Experience with pharmacokinetic analysis software and understanding of PK and PK/PD principles for interpreting results (preferred).  

• ​Good understanding of GLP/GCP regulations and their application in bioanalytical contexts. 

• ​Demonstrated ability to work independently in a fast-paced biotech environment while thriving in a collaborative, and global multidisciplinary team setting. 

• ​Excellent oral and written communication and time-management skills, and the ability to handle multiple projects simultaneously. 

• ​Strong work ethic and ability to work independently with minimal supervision.​ 

Education- ​​Ph.D. or equivalent degree in Analytical chemistry or a related field with minimum 5 years' experience. Level will be commensurate with experience and accomplishments.

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*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor at this time. 

*Candidate must be able to pass a background investigation. 

*Unable to work with 3rd party candidates or agencies. 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Orum Therapeutics is an Equal Opportunity Employer (EOE).