About the job
Join Kyowa Kirin, a rapidly expanding global specialty pharmaceutical leader, where we leverage cutting-edge biotechnologies to innovate and deliver groundbreaking therapies across four critical disease areas: bone and mineral disorders, intractable hematologic conditions, hematology oncology, and rare diseases. Our mission is to translate scientific advancements into meaningful treatments that fill existing gaps in healthcare, progressing from drug discovery to development and commercialization. Headquartered in Princeton, NJ, with additional offices in California, North Carolina, and Mississauga, Ontario, we are committed to improving lives.
Position Overview:
The Senior Manager, Bioanalysis is essential in propelling Kyowa Kirin’s drug development pipeline forward. This role involves providing strategic bioanalytical support to both cross-functional and cross-regional teams throughout early- and late-phase clinical studies, acting as a subject matter expert (SME) within the Bioanalysis sub-team of our global Clinical Pharmacology department. You will oversee regulated bioanalytical processes conducted at CROs across all phases of clinical sample analysis, integrating a comprehensive understanding of regulatory frameworks and fostering effective collaborations across global teams to enhance program strategies and execution.
Key Responsibilities:
- Manage pharmacokinetic (PK) and immunogenicity bioanalyses conducted at CROs, including site visits and assay troubleshooting with internal SME support.
- Offer bioanalytical insights on PK and immunogenicity requirements for clinical projects to global clinical study teams, advising on sample collection, processing, storage, and data transfer protocols.
- Review clinical study protocols, and produce bioanalytical summaries and reports for clinical pharmacology documentation and CSR submissions.
- Create summary documents for regulatory submissions and engage in strategic dialogues with regulatory authorities.
- Collaborate extensively with Japanese counterparts on bioanalytical method development, CRO qualification/selection, and process enhancements, including drafting work instructions (WIs) and Standard Operating Procedures (SOPs), and co-leading task forces.
- Ensure compliance with current global and local bioanalytical guidelines and GxPs.
- Simultaneously manage multiple projects involving method validation and sample analysis activities, supported by internal team members.