<div class="content-intro"><p>Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.</p></div><p><strong>Role Summary:</strong></p><p>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. </p><p>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.</p><p><strong>Key Responsibilities:</strong></p><ul><li>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 </li><li>Responsible for relevant input in clinical study documents and associated systems (including clinical trial protocol, Informed consent forms, lab manuals, etc.)</li><li>Responsible for managing sample analysis timelines with vendors as well as creating and maintaining internal Spyre dashboards/projections for stakeholder visibility and planning</li><li>Oversee sample logistics and data delivery; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases </li><li>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</li><li>Collaborate with Clinical Operations for sample management, consent review, storage, and/or sample destruction per requirements</li><li>Collaborate with Data Management teams on data transfer agreements, and data specification documents</li><li>Oversee EC/IRB biomarker-related inquiries, ensuring consistent responses across studies while maintaining biomarker standard language and study timelines</li><li>Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’</li><li>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 </li><li>Support communications and building relationships with key external partners including CROs, vendors and other external collaborators</li><li>Proactively identify and resolve and/or escalate study-related issues</li><li>Spearhead process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes</li><li>Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels</li><li>Other duties as assigned</li></ul><p><strong>Ideal Candidate:</strong></p><ul><li>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.</li><li>Minimum of 3+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred</li><li>Knowledge of GxP requirements, ICH, Global Regulations, Ethics and Compliance</li><li>Proficient in MS Office (including Excel, Word and PowerPoint), Adobe, SmartSheet, etc. </li><li>Experience in using sample management/tracking systems, i.e., Laboratory Information Management Systems (LIMS)</li><li>Experience with IBD or rheumatic disease is preferred</li><li>Fast and curious learner that thrives in fast-paced dynamic environment, with a proven ability to excel amid rapid change</li><li>Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions</li></ul><p><strong>What We Offer:</strong></p><ul><li>Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.</li><li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.</li><li>Unlimited PTO</li><li>Two, one-week company-wide shutdowns each</li><li>Commitment to provide professional development opportunities.</li><li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li></ul><p>The expected salary range offer for this role is $130,000 to $145,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. </p><div class="content-conclusion"><p>As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.</p><p>Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p><p>Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div>