Head, Bioanalysis Operations

Astellas Pharma•Northbrook, IL

7d•Remote

About The Position

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. Testing and reporting in clinical studies in partnership with Clinical Operations and Data Management. Develop and strengthen PK and biomarker bioanalysis capabilities by aligning strategy with operational feasibility to meet clinical development objectives. Build and maintain effective working relationships with key internal stakeholders, including Clinical Pharmacology, Translational Medicine, and Modeling & Simulation/Pharmacometrics. Meet or exceed all Astellas Development/ corporate goals for clinical study timelines/ deadlines. Expand global bioanalysis capabilities across research and development functions, with a strong focus on collaboration with the preclinical BA/BM group. Contribute to interaction with regulatory authorities related to Bioanalysis issues and registration. Leadership position with direct reports.

Requirements

Advanced degree (Ph.D. or equivalent) with at least 8 years experience in an industry setting, in drug research/development, with demonstrated track record of application of PK/ PD and biomarkers approaches across multiple modalities.
Demonstrated successful program leadership and multi-project coordination
Solid understanding of regulatory interactions with the FDA and other global regulatory agencies.
Ability to influence and deliver results in a cross-functional team environment with strong leadership.
Excellent written and verbal communication skills

Nice To Haves

Proven management experience with demonstrated leadership capabilities.
Experience in drug development for complex modalities such as bispecific antibody, ADC, cell therapy, mRNA, gene therapy.
Background in research activities and/or bioanalytical or analytical work, including hands-on experience in bioanalytical laboratory settings.
Have the ability to troubleshoot/ develop and validate novel bioanalytical methods for the measurement of drug, metabolites and biomarkers in collaboration with CROs/ academic collaborators
International recognition as an expert in the field.

Responsibilities

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.

Benefits

Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company fleet vehicle for eligible positions
Referral bonus program

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