Spyre Therapeutics

Clinical Operations

• Direct input into the clinical operational strategy and plans.
• Implementation and management of the clinical operational plans and programs to meet corporate goals and objectives.
• Work with Clinical Development to draft clinical trial protocols and other trial-related documents, and work with other departments and functions to implement clinical trial protocols.
• Serve as an interface with clinical investigators.
• Effectively negotiate contracts with consultants, clinical investigators, and contract research organizations.
• Conduct funding negotiations with clinical sites when necessary.
• Support the management of site-related activities, development of tracking tools, and manage recruitment timelines.
• Prepare updates on study progress.
• Prepare the study budgets, and track payment of contracts related to the project.
• Generate clinical department SOPs and conduct trainings as necessary.
• Regularly make presentations to senior staff members and participate in relevant Development Team meetings.
• Procure and oversee outside vendors and consultants as required.
• Supervise and manage activities of clinical operations personnel.
• Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials.
• Attend scientific and external training meetings as needed.
• Other clinical operations activities as required.

Director, Clinical Operations

Supply Chain

• Own the global clinical drug product supply strategy for assigned programs, ensuring alignment with clinical development timelines, regulatory requirements, and corporate objectives.
• Lead end-to-end clinical supply planning and execution to ensure uninterrupted, on-time, and compliant delivery of drug product throughout global clinical trials.
• Provide strategic direction for scaling drug product supply capabilities from Phase 2 through Phase 3 and commercial readiness.
• Direct all clinical drug product supply chain activities, including demand forecasting, supply planning, IRT support, labeling strategy, packaging and labeling operations, release, distribution, inventory management, expiry strategy, and cold chain oversight.
• Establish and maintain robust processes, systems, and controls to ensure compliance with GMP, GDP, and global regulatory requirements.
• Perform short-, medium-, and long-term supply forecasting and oversee monthly forecasting and production planning cycles.
• Provide senior technical oversight of drug product formulation, manufacturing, packaging, and labeling activities conducted by external CMOs.
• Evaluate and implement new technologies, systems, and delivery approaches to improve supply robustness, efficiency, and scalability.
• Ensure technical and supply chain readiness for regulatory submissions and inspections.
• Lead CMO and vendor strategy, including selection, contracting, performance management, change control, and issue resolution across all outsourced drug product supply activities.
• Oversee procurement of comparator drug products and matching placebo, as required.
• Build strong, performance-driven partnerships with external vendors to support clinical and future commercial needs.
• Provide leadership oversight of quality-related activities impacting clinical drug product supply and participate in quality improvement initiatives.
• Serve as a senior subject matter expert in clinical supply GMP, GDP, and related business processes.
• Proactively identify risks, trends, and opportunities for continuous improvement across drug product technical operations and supply chain processes.
• Author, review, and approve clinical and technical documentation, including clinical labels, packaging batch records, protocols, pharmacy manuals, and regulatory submissions (IND, IMPD, NDA).
• Own clinical drug product supply budgets for assigned programs, ensuring accurate cost forecasting and alignment with inventory and demand strategies.
• Act as a key cross-functional leader, providing clear communication, decision-making, and guidance to internal teams and senior management.

Director, Drug Product & Supply Chain

Manager

• Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival
• Conduct oversight of and provide guidance to data management CROs to ensure that data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
• Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.)
• Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT, eCOA)
• Coordinate cross functional data review and provide proactive review of data trends and issue resolution
• Other duties as assigned

Senior Manager, Data Management

Medical writer

• Lead projects, submissions and documentation for programs independently. Collaborate with manager and other functions on planning and appropriate resourcing.
• 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.
• Possible oversight of contract medical writers, ensuring high-quality documents delivered and timelines met.
• 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.

Associate Director, Medical Writer

Program Manager

• Meticulously maintain and track detailed integrated program timelines ensuring alignment across functions on dependencies and assumptions crucial for corporate goals. Recognize and alert stakeholders when projects are on or near critical paths to key milestones. Communicate progress transparently and address issues promptly.
• Manage cross-functional meetings efficiently, ensuring clear objectives, documenting outcomes, information, and action items, and following up on tasks with team members.
• Develop and upkeep project documentation including meeting materials, minutes, action item logs, decision trackers and dashboards.
• Proactively identify, monitor, communicate and propose mitigation options for program risks.
• Collaborate across functions including Pre-clinical, Clinical Development, Technical Operations, Regulatory, Quality, Finance and Legal to ensure alignment.
• Play a pivotal role within the Portfolio Management and Operations team, providing guidance on best practices, developing team resources, tools and templates, and nurturing a culture of excellence, innovation, and accountability.
• Other duties as assigned

Director, Clinical Operations

Director, Drug Product & Supply Chain

Senior Manager, Data Management

Associate Director, Medical Writer

Executive Director, Program Management