This role involves close collaboration with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Clinical Development, Regulatory Affairs, and external laboratories. You will provide scientific and operational oversight of pharmacokinetic (PK), immunogenicity (ADA/NAb) and pharmacodynamic (PD) assays supporting drug development through non-clinical and clinical programs.
Key Responsibilities:
Bioanalytical Strategy & Program Support
- Contribute to the development and execution of bioanalytical strategies within non-clinical and clinical development programs.
- Independently lead bioanalytical activities and proactively address scientific and operational challenges in a cross-functional environment.
- Support the selection, development, qualification/validation and implementation of PK, immunogenicity (ADA/NAb), and PD assays.
- Provide scientific input to relevant clinical and non-clinical development documentation.
- Ensure bioanalytical activities are aligned with overall program objectives, scientific best practices, and applicable regulatory expectations.
- Support bioanalytical assay strategy discussions for non-clinical and clinical studies.
- Ensure bioanalytical activities are conducted in accordance with applicable GxP requirements and regulatory guidance.
- Serve as the primary scientific contact for external bioanalytical laboratories and service providers.
- Support external vendor selection, qualification, and governance activities.
- Monitor laboratory performance, data quality, and timelines, and support issue resolution.
- Manage outsourced assay development, validation, and clinical and non-clinical sample analysis activities.
- Review and approve method validation reports, clinical and non-clinical sample analysis plans and reports, data transfer specifications, and other study-related documentation.
- Evaluate bioanalytical results and provide scientific recommendations to support program decision-making.
- Support the integrated interpretation of PK, ADA, NAb, and PD data.
- Contribute to internal decision-making, cross-functional discussions, study reports, regulatory documentation, and scientific publications.
- Act as a scientific interface between internal stakeholders, external consultants, and bioanalytical service providers, ensuring alignment on assay strategy, study execution, and interpretation of bioanalytical data.
- Work closely with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Clinical Development, Regulatory Affairs, and external subject matter experts and consultants supporting CatalYm's development programs.
- Present bioanalytical strategies, results, and recommendations to project teams and management.