Manager, Translational Operations

Role Summary

We are seeking a highly organized and detail-oriented Manager of Translational Operations to join our growing team at Spyre. As a key member of the Translational Sciences team, you will drive biosample strategies and implementation, overseeing multiple global clinical trials. You will collaborate cross-functionally both internally and externally to optimize the collection and utilization of our clinical trial samples and data to meet protocol requirements and scientific goals.

This role is critical in ensuring the integrity, traceability, and timely delivery of biospecimens to our analytical labs and managing timelines. You will be responsible for operational management of PK, immunogenicity, and biomarker samples across our labs and third-party vendors. This role will report to the Executive Director & Head of Translational Science and will interact with multiple other functional teams within Spyre (Clinical Development, Clinical Operations, Nonclinical, Quality, Project Management, Regulatory, etc.). This role requires a combination of scientific, strategic, and project management expertise with excellent communication skills and attention to detail.

Responsibilities

• Leading the implementation of the biosample strategy as described in our clinical protocols and lab manuals to ensure high quality bioanalytical, biomarker, and diagnostic biosample analysis for multiple priority clinical trials
• Responsible for relevant input in clinical study documents and associated systems (including clinical trial protocol, Informed consent forms, lab manuals, etc.)
• Responsible for managing sample analysis timelines with vendors as well as creating and maintaining internal Spyre dashboards/projections for stakeholder visibility and planning
• Oversee sample logistics and data delivery; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases
• Responsible for the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed. Work with cross-functional areas to continuously improve processes
• Collaborate with Clinical Operations for sample management, consent review, storage, and/or sample destruction per requirements
• Collaborate with Data Management teams on data transfer agreements, and data specification documents
• Oversee EC/IRB biomarker-related inquiries, ensuring consistent responses across studies while maintaining biomarker standard language and study timelines
• Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’
• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines. Serve as a subject matter expert (SME) and resource for one or more processes in Translational Sciences
• Support communications and building relationships with key external partners including CROs, vendors and other external collaborators
• Proactively identify and resolve and/or escalate study-related issues
• Spearhead process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes
• Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels
• Other duties as assigned

Qualifications

• Bachelor’s degree in life sciences with 5+ years of R&D drug development experience within the biotech/pharmaceutical environment. More advanced degrees welcome but not required.
• Minimum of 3+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred
• Knowledge of GxP requirements, ICH, Global Regulations, Ethics and Compliance
• Proficient in MS Office (including Excel, Word and PowerPoint), Adobe, SmartSheet, etc.
• Experience in using sample management/tracking systems, i.e., Laboratory Information Management Systems (LIMS)
• Experience with IBD or rheumatic disease is preferred
• Fast and curious learner that thrives in fast-paced dynamic environment, with a proven ability to excel amid rapid change
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions