Orum Therapeutics is seeking a highly motivated and accomplished scientist to lead the Bioanalytical (BioA) and PK/PD function. This role is designed for a technical expert who thrives at the intersection of large and small molecule analysis, specifically focused on the complex characterization of Antibody-Drug Conjugates (ADCs). As a key scientific lead, you will orchestrate the bioanalytical lifecycle — from internal method innovation to global CRO oversight — ensuring high-quality data generation in a GLP/GCP environment. Beyond assay management, you will serve as a strategic partner in project teams, leveraging pharmacokinetic modeling to translate data into actionable insights that drive candidate selection and program progression.
Principal Duties and Responsibilities
- Design and execute integrated Bioanalytical and PK/PD strategies for ADC programs, utilizing the three-analyte quantification approach (Total Ab, Conjugated, and Free Payload) from lead optimization to IND filing.
- Oversee in vitro and in vivo ADME studies, including payload metabolism, drug-drug interactions (DDI), and transporter assays, to define the metabolic fate of the ADC and the released payload.
- Provide high-level technical oversight for hybrid bioanalytical workflows, specifically bridging LBA and LC-MS/MS platforms to ensure robust quantification of complex modalities.
- Lead CRO selection and management, serving as the primary point of contact for method transfer, development, validation, and troubleshooting of proprietary assays under aggressive timelines.
- Review and approve SOPs, validation reports, and bioanalytical study plans in alignment with GLP/GCP standards and current FDA guidance.
- Act as the BioA/PK subject matter expert (SME) within multidisciplinary project teams, collaborating with Research & Development and Clinical teams to drive program milestones.
- Drive continuous improvement by evaluating emerging technologies to enhance the throughput and quality of ADC characterization.
- Execute an integrated role that bridges high-level scientific leadership and direct lab-based contributions, ensuring seamless translation from internal innovation to external CRO execution.
- Serve as the lead author for BioA and PK sections of regulatory submissions (IND/IB), ensuring full compliance with GLP/GCP and current FDA/EMA bioanalytical guidance.
Skills, Abilities & Competencies
- Extensive experience in pharmacokinetic (PK) and biodistribution studies of Antibody-Drug Conjugates (ADCs), including application of advanced bioanalytical methods such as LC-MS/MS for small-molecule quantitation and MSD-based ligand-binding assays (LBAs).
- Proven track record in developing, validating, and implementing bioanalytical assays for ADC modalities, including total antibody, free and conjugated payload, and anti-drug antibodies (ADA) assays, in support of preclinical and clinical PK studies.
- In-depth understanding of ADME principles and drug discovery/development workflows, including screening strategies from early feasibility through candidate nomination.
- Experience in non-compartmental analysis of PK data, with hands-on experience in PK/PD modeling and simulation, population PK analysis, and meta-analysis is a plus.
- Working knowledge of GLP and GCP regulations and their application within bioanalytical and clinical study environments.
- Demonstrated ability to operate independently in fast-paced biotech settings while effectively collaborating within cross-functional, global teams.
- Excellent communication, organizational, and time-management skills, with the ability to manage multiple priorities and deliver high-quality results.
- Strong work ethic with a high degree of accountability, initiative, and ability to work with minimal supervision.
Education
Ph.D. or equivalent degree in Analytical Chemistry or a related field with a minimum of 5 years' experience. Level will be commensurate with experience and accomplishments.
*U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor/transfer 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).
