Head, Bioanalysis Operations

Job Opportunity At Astellas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

1. Provide global vision and strategic direction for establishing and validating clinical bioanalytical methods for PK, PD and immunogenicity across diverse modalities and biology, in close collaboration with the preclinical BA/BM group.
2. Testing and reporting in clinical studies in partnership with Clinical Operations and Data Management.
3. Develop and strengthen PK and biomarker bioanalysis capabilities by aligning strategy with operational feasibility to meet clinical development objectives.
4. Build and maintain effective working relationships with key internal stakeholders, including Clinical Pharmacology, Translational Medicine, and Modeling & Simulation/Pharmacometrics.
5. Meet or exceed all Astellas Development/ corporate goals for clinical study timelines/ deadlines.
6. Expand global bioanalysis capabilities across research and development functions, with a strong focus on collaboration with the preclinical BA/BM group.
7. Contribute to interaction with regulatory authorities related to Bioanalysis issues and registration.
8. Leadership position with direct reports.

Responsibilities and Accountabilities:

• To define, develop and lead the establishment of global bioanalysis standards that upon implementation, guarantee the generation and availability of appropriate Bioanalysis contributions across all phases of development and at registration
• Responsible to implement biomarker/ PK activities within the majority of planned clinical studies.
• Ensure that all activities associated with Bioanalytical work is documented and archived.
• Responsible for interfacing and collaborating with key Research and Development functions
• Responsible for optimal allocation and management of expertise and resources
• At the project level, ensure that clinical tests are precise/ accurate and robust. These tests would satisfy regulatory bodies and would additionally follow local guidances.
• Reports to Head, Translational & Biomedical Science
• Have direct reporting PK and Biomarker Bioanalysis scientists who are responsible for providing contributions to individual projects
• Staff from the section will work on 15 - 30 projects from P0 through registration.