Spyre Therapeutics

Financial Planning and Analysis

• Perform full-cycle general ledger accounting, including preparing schedules and journal entries, and performing various account reconciliations (including, but not limited to, cash, investments, prepaids, and accruals)
• Ensure reporting calendar is met by working cohesively with the accounting/finance team
• Manage multiple tasks under tight deadlines with strong attention to detail and accuracy
• Collaborate with other departments and third parties to facilitate the timely and accurate receipt of financial data
• Provide detailed support and timely communications to assist with the external audit process
• Assist with quarterly analysis and reporting of financial statements
• Assist with maintaining the company’s ERP and other accounting systems
• Formulate and recommend system and process changes through evaluation, analysis of controls, and application of GAAP
• Maintain ownership and documentation of business processes and key controls for Sarbanes- Oxley compliance
• Understand accounting policies and procedures
• Ad-hoc reporting and analysis
• Other duties as assigned

Senior Accountant, Finance

Medical Director

• Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD.
• Design, plan, and oversee the execution of clinical studies, with a focus on proof-of-concept and later-stage development.
• Partner with teams across Biostatistics, Regulatory Affairs, Development Operations, Translational Science, and other key functions to ensure cohesive and efficient program execution.
• Contribute medical and scientific content for regulatory documents including INDs, Investigator Brochures, Clinical Study Reports, and regulatory submissions and responses.
• Ensure participant safety through proactive safety monitoring, data review, and clinical judgment in response to emerging data.
• Serve as a primary medical representative for assigned programs, interfacing with investigators, academic experts, and key opinion leaders (KOLs).
• Provide medical leadership within clinical teams and mentor as the organization grows.
• Support strategic portfolio decisions and organizational initiatives as needed.

Executive Medical Director, Clinical Development

Supply Chain

• Plan and deliver on-time, compliant clinical supply per the clinical development plan
• Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan
• Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
• Author, review, and/or approve related clinical and technical documents, including but not limited to: clinical label text, packaging batch records, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA
• Manage existing clinical supply vendors through quoting, execution, changes, and close out, ensuring high performance delivery across all outsourced activities
• Support new vendor identification, selection, and onboarding for future phases and/or capabilities
• Serve as a subject matter expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes
• Responsible for oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations
• Performs supply forecast modeling (short, medium and long-term) and supports monthly forecasting and production process
• Ensures product requirements and costs for the budget are complete and in place for assigned projects
• Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions.
• Manages the procurement of comparator drug products and matching placebo as required
• Other duties as assigned.

Director, Supply Chain

Medical writer

• Lead projects, submissions or programs independently.
• Provide medical writing strategy to program teams, ensuring business goals and regulatory needs are met.
• Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and meeting responses.
• Develop timelines in collaboration with our team. Plan for required data with SMEs, if applicable.
• Co-author documents with relevant cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments).
• Coordinate QC, finalization and publication of documents
• Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required.
• Ensure key messages are clear and consistent across and within documents.
• Represents the medical writing function in cross-functional teams.
• Provide status updates to keep teams, department, and leadership informed.
• Identify risks and contribute to risk mitigation or contingency planning for submission activities.
• Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials.
• Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.

Senior Manager, Medical Writer

Translator

• 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

Manager, Translational Operations

• Author clinical study protocols, amendments, IBs, and other supporting documents
• Review or develop document timelines in collaboration with our team and our CROs. Ensure that study documents will be authored, reviewed, and finalized in time for regulatory submission(s) and study execution.
• Co-author protocols and IBs with cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments).
• Coordinate the finalization and publication of documents.
• Review or contribute to supporting study documents, including (but not limited to) informed consent forms, study charters, or pharmacy manuals, if required.
• Author CSRs, clinical and nonclinical data summaries for INDs, CTAs, BLAs, and MAAs
• Work closely with clinical development, clinical pharmacology, translational science, data management, and/or biometrics SMEs, as well as the regulatory affairs and medical writing teams, to plan for the data that we expect to report in our CSRs. Co-author robust CSR shells in preparation for database lock(s).
• Co-author CSRs with accurate and concise interpretations of the results. Manage review cycles.
• Prepare clinical and nonclinical summaries for submission to regulatory agencies. Ensure key messages are clear and consistent across and within documents.
• Coordinate data integrity reviews of CSRs and data summaries, ensuring that the data and interpretations are consistent with TLFs and raw data.
• Assist with responses to information requests from regulators in a professional and efficient manner.
• Identify risks and contribute to risk mitigation or contingency planning for submission activities.
• Contribute to the maintenance of document templates, job aids, and training materials.
• Identify opportunities for process improvement.
• Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.
• Other duties as assigned.

Senior Medical Writer

Clinical Operations

• Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion.
• Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements.
• Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites.
• Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
• Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
• Responsible for implementation and oversight of Trial Master File for inspection readiness.
• Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
• Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
• Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members.
• Provide study updates and reports, inclusive of study risks and issues.
• Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings.
• Responsible for ongoing study data reviews and data cleaning activities.
• Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities.
• Manage trial-level quality risk management.
• Oversee study supplies management.
• Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes.
• Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
• Other duties as assigned.