Diagnostic Operations Manager, Precision Medicine

Astellas Pharma • Northbrook, IL

1d • Remote

About The Position

The Precision Medicine and Diagnostics team is dedicated to the co-development
of companion diagnostics alongside our drugs, as well as providing diagnostic
testing for patient selection and stratification in clinical studies across all
phases of development.

As a Diagnostic Laboratory Operations Manager, you will oversee diagnostic
testing at external central laboratories for patient eligibility and biomarker
stratification in clinical studies, ensuring compliance with regulatory and
quality standards. You will manage vendor relationships, oversee biosample
logistics, and collaborate with study teams to deliver high-quality diagnostic
testing and data management support.

Requirements

• BSc with 3+ years or MSc/PhD with 2 years of relevant experience in lab operations and clinical research.
• Technical expertise in biomarker testing methods, including immunohistochemistry, immunofluorescence, and DNA/RNA assays.
• Experience in vendor management, contract negotiation, and human biosample logistics within clinical trials.
• Familiarity with Laboratory Information Management Systems (LIMS).
• Proven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
• Strong collaboration skills with the ability to present findings to both technical and non-technical stakeholders.

Nice To Haves

• Experience of diagnostic test development under Design Control in compliance with FDA Quality System Requirements or other Health Authority (e.g. EU, Japan, China) regulatory requirements.
• FDA IDE, EU IVDR experience for clinical studies.

Responsibilities

• Oversee diagnostic testing at external central diagnostic laboratories, ensuring that assay validation, laboratory accreditation and quality management system requirements are met for specific clinical trials, and assist in implementing corrective actions as needed.
• Collaborate with clinical and diagnostic teams on laboratory vendor assessment, selection, contracting and execution of services.
• Serve as the primary contact for clinical study teams and companion diagnostic partners, managing laboratory vendors to ensure high-quality biospecimen analysis in adherence to contracted testing specifications.
• Oversee logistics of biosamples from trial sites to central laboratories, ensuring sample integrity, traceability, and compliance with timelines.
• Work with clinical study teams and external vendors to develop diagnostic monitoring and communication plans and ensure proper design of electronic case report forms and data transfer specifications.
• Support data management and clinical study teams on central laboratory diagnostic data reconciliation.
• Troubleshoot and resolve issues related to sample collection, processing, testing, storage, and shipment in collaboration with clinical operations, vendors and diagnostic partners.
• Member of Precision Medicine & Dx project teams supporting drug programs and trials
• Reports to Global Head of Precision Medicine and Diagnostics.
• Matrixed relationship to colleagues on Global Development Teams including Precision Medicine & Diagnostic Lead, Alliance Management, Biosample Management, Project Management, Clinical Science, Data Science, Regulatory Affairs and Translational Medicine.
• Manages lab operations for 4-8 trials within 2-4 drug programs based on complexity and extent of Dx activities

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 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
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level