Associate Director, Bioanalysis

Otsuka is looking for an energetic, motivated, talented individual to join the Bioanalytical team.  In addition to regulated bioanalysis, innovative measurement projects that focus on clinical trial outcomes and process improvement are just a part of what we invest our energy in.  If you are looking for an opportunity to pioneer the field of bioanalysis, look no further.

The Associate Director, Bioanalysis is responsible for managing the outsourced measurement in biological fluids to support clinical drug development, with focus on biological drug concentrations and immunogenicity.  He/she will have proficient knowledge in global bioanalytical guidance regulations and understanding of how bioanalytical data flows from the laboratory to regulatory submissions.  Strong analytical experience, particularly with LBA, large molecule mass spectrometry, and cell-based technologies, such as flow cytometry, as well as experience with vendor management is strongly preferred.

The individual will be responsible for managing vendors who generate bioanalytical data and ensuring data is auditable, submission-ready and of high quality.  He/she will contribute to method development problem solving and support data-driven projects, such as biospecimen management.  In addition, he/she will be responsible for surveying the clinical trial measurement landscape and make recommendations on process and technological improvements. The individual should maintain awareness of evolving trends in analytical techniques to support clinical trials and defend innovation projects to the project teams.  

This role requires excellent verbal and written communication skills, strong organizational skills, and the ability to manage multiple projects in different stages of development under strict deadlines and fluctuating priorities.
** Key responsibilities
*** Provide strategic oversight for bioanalytical method development and validation, including troubleshooting and optimization.
* Establish, cultivate, and manage relationships with contract research organizations (CROs) and external principal investigators.
* Serve as a key contributor on project teams by presenting findings, interpreting scientific results, and recommending next steps or addressing issues.
* Support regulatory submissions through drafting and reviewing submission-ready reports.
* Manage outsourced bioanalytical vendors to ensure adherence to timelines, data integrity, and compliance with global guidelines.
* Ensure bioanalysis is conducted and reported in alignment with Global Bioanalytical Guidance for regulatory submissions supporting new chemical entities and biologics.
* Oversee vendor activities, including review of analytical plans, validation strategies, and data packages.
* Provide expert oversight of method performance and critically evaluate validation plans and reports.
* Stay informed on emerging trends and technologies to advance bioanalytical capabilities, advocate for innovative solutions within project teams.
** Qualifications/ Required
*** PhD with at least 3 years of relevant experience, or B.S. or M.S. degree with at least 5 years of relevant experience.
* Proficient knowledge of regulated bioanalysis as defined by global guidances in support of pharmacokinetics in drug development.
* Solid understanding of bioanalytical methodology, including ELISA, ECL, flow cytometry, LC-MS/MS, etc.
* Large molecule bioanalysis experience required; small molecule is preferred.
* Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance.
* Demonstrated ability to work on multiple complex projects simultaneously with high attention to detail.
* Team player with strong organizational, inter-personal, written and communication skills.
** Disclaimer
* * This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as…