Head, Bioanalysis Operations

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. For more information on Astellas, please visit our website at www.astellas.com.

This position is fully remote. 

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:

• 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.

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.

Required

• 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

Preferred

• 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.

Salary Range

$229,600 - $360,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

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