Spyre Therapeutics is a cutting-edge biotechnology company specializing in developing innovative therapies for a wide range of diseases. Founded in 2010, the company has been at the forefront of revolutionizing the healthcare industry with its groundbreaking research and development efforts. Spyre Therapeutics' commitment to advancing medical science has led to the creation of novel treatments that have the potential to significantly improve patient outcomes and transform the standard of care.

spyre-therapeutics

<div class="content-intro">Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.</div>Role Summary:
The Executive Director, Clinical Operations, will provide strategic leadership and hands-on oversight of global clinical trials, ensuring trials are delivered within agreed timelines and budgets and meet quality standards and applicable regulatory requirements.
This individual will translate clinical development objectives into operational plans and lead trial execution from start-up through close-out. Responsibilities include trial planning, enrollment, site engagement, CRO and vendor oversight, budget management, risk mitigation, and operational readiness for key trial milestones.
The Executive Director will partner closely with Clinical Development and other functions, serve as a key point of contact for CROs and clinical investigators, and develop and mentor Clinical Operations personnel. Success requires sound judgment, accountability, and the ability to balance strategic leadership with hands-on execution in a growing biotechnology company.
Key Responsibilities:
<ul>
<li>Lead the development and execution of clinical operational strategies and study plans aligned with clinical development priorities and corporate objectives. Oversee global clinical trial activities from feasibility and start-up through enrollment, trial conduct, database lock, and closeout.</li>
<li>Establish and manage trial timelines, budgets, resource plans, and performance metrics; identify risks early, establish mitigation plans, and drive timely resolution of issues.</li>
<li>Partner with Clinical Development and cross-functional colleagues to assess protocol feasibility and contribute operational input to protocols, informed consent forms, study plans, and other trial-related documents.</li>
<li>Implementation and management of the clinical operational plans and programs in order to meet corporate goals and objectives.</li>
<li>Lead CRO and vendor selection, contracting, governance, and performance oversight, ensuring clear responsibilities, effective communication, and accountability for deliverables.</li>
<li>Oversee country and site feasibility, site selection, activation, monitoring, and closeout activities.&nbsp;</li>
<li>Build effective relationships with clinical investigators and site teams to support trial execution, participant recruitment and retention, and timely issue resolution.</li>
<li>Develop and oversee enrollment strategies along with Medical Affairs, monitor recruitment performance, and implement actions to address enrollment challenges.</li>
<li>Partner with Data Management, Biometrics, Clinical Development, and other functions to support data quality, timely query resolution, database lock, and clinical trial reporting.</li>
<li>Develop and manage study budgets, oversee contract and budget negotiations, and monitor forecasts, invoices, and payments in partnership with Finance and Legal.</li>
<li>Partner with Quality to maintain inspection readiness, support audits and regulatory inspections, and ensure timely resolution of findings and implementation of corrective actions.</li>
<li>Develop and maintain Clinical Operations SOPs, processes, and tools; provide training and drive improvements that support quality and efficient execution.</li>
<li>Provide clear, actionable updates to senior leadership and Development Teams on study progress, budget performance, risks, and decisions requiring escalation.</li>
<li>Lead, mentor, and develop Clinical Operations personnel, establishing clear expectations and fostering collaboration, ownership, and high-quality execution.</li>
<li>Maintain current knowledge of relevant therapeutic areas, clinical trial practices, and applicable regulatory requirements.</li>
<li>Regularly make presentations to senior staff members and participate in relevant Development Team meetings.</li>
<li>Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials.</li>
<li>Attend scientific and external training meetings as needed.</li>
<li>Other clinical operations activities as required.</li>
</ul>
Ideal Candidate:
<ul>
<li>Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred. A minimum of 10 years of global clinical research experience within the pharmaceutical or biotechnology industry.</li>
<li>Late-stage dermatology clinical trial experience is strongly preferred.</li>
<li>Demonstrated success overseeing clinical trial planning, start-up, enrollment, monitoring, data cleaning, database lock, closeout, and clinical trial reporting.</li>
<li>Experience leading CROs and other clinical service providers, including vendor selection, contract negotiation, governance, and performance management.</li>
<li>Strong financial and operational management skills, including study budgeting, forecasting, resource planning, and risk management.</li>
<li>Thorough understanding of Good Clinical Practice and applicable local and global clinical trial requirements, with experience supporting audits, regulatory inspections, and inspection readiness.</li>
<li>Experience contributing to protocols, SOPs, clinical study reports, and regulatory submissions preferred.</li>
<li>Demonstrated ability to lead and develop Clinical Operations personnel and guide cross-functional teams through influence.</li>
<li>Excellent communication, interpersonal, and decision-making skills, including the ability to communicate complex issues and recommendations clearly to senior leadership.</li>
<li>Ability to manage competing priorities, adapt to changing needs, and combine strategic thinking with hands-on execution in a growing organization.</li>
</ul>
What We Offer:
<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 &amp; 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>
The expected salary range offer for this role is $285,000 to $310,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;<div class="content-conclusion">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.
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.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div>

Executive Director, Clinical Operations

<div class="content-intro">Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.</div>Role Summary:
The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.
Key Responsibilities:
<ul>
<li>Lead the biometrics team including statistician, data manager, and statistical programmer at a program level</li>
<li>Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies</li>
<li>Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies</li>
<li>Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings</li>
<li>Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data</li>
<li>Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines</li>
<li>CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines</li>
<li>Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities</li>
<li>Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses</li>
<li>Other duties as assigned</li>
</ul>
Ideal Candidate:
<ul>
<li>PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.</li>
<li>Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology is preferred.</li>
<li>Experience with regulatory submissions and interactions with regulatory agencies.</li>
<li>Proficiency in statistical software (e.g., SAS, R) and data management systems.</li>
<li>Experience with CDSIC including SDTM, ADaM, CDASH</li>
<li>Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.</li>
<li>Excellent communication and interpersonal skills, along with organizational skills.</li>
<li>Ability to work collaboratively in a multidisciplinary team environment.</li>
</ul>
What We Offer:
<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 &amp; 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>
The expected salary range offer for this role is $295,000 to $314,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;<div class="content-conclusion">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.
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.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div>

Senior Director, Biostatistics

Senior Scientist, Translational Science

<div class="content-intro">Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.</div>Role Summary:
The Director, Drug Safety Physician, will play a pivotal role within the Drug Safety &amp; Pharmacovigilance (DSPV) team, helping to advance the development of our cutting-edge antibody portfolio. This position’s deliverables include Individual Case Safety Report (ICSR) review and aggregate safety monitoring (DSUR, etc.), oversight of cases/Analysis of Similar Events (AOSEs) for expedited safety reporting, contributing to ongoing safety assessment, safety surveillance, signal detection, risk management planning and safety strategy. The role will also provide medical safety input into key clinical trial document reviews, including protocols, IB, ICF, ensuring pharmacovigilance compliance with global regulatory requirements.&nbsp; The position reports to Sr VP, Drug Safety and Pharmacovigilance with a dotted line reporting relationship to the Medical Review Lead.&nbsp;
Key Responsibilities:
<ul>
<li>Perform triage and medical review of ICSRs (in and/or outside the global safety database), and oversight of cases/AOSE for expedited safety reporting</li>
<li>Lead cross-functional medical review discussions pertaining to Individual Case Safety Report (ICSR) review</li>
<li>Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of relevant clinical trial documents and regulatory filings</li>
<li>Participates in and/or leads review of scientific literature, including preparation of written summaries to support aggregate safety analyses</li>
<li>Participate in safety data review including safety surveillance activities and the evaluation &amp; management of safety signals emerging from any data source</li>
<li>Participate and co-present cases at safety management team (SMT) and safety review team (SRT) meetings and co-lead safety surveillance and signal management meetings</li>
<li>Participate in process improvement projects related to medical review and assessment, safety surveillance, and relevant aspects of PV compliance&nbsp;</li>
<li>Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, safety management plans, and safety surveillance plans</li>
<li>Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings &nbsp;</li>
<li>Collaborate closely and assists the Medical Review Lead and other physicians on the team on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations (relevant to medical review of ICSRs and/or safety surveillance aspects), and provides ongoing input into study protocols, periodic safety reports (DSURs), safety management plans etc. &nbsp;Lead epidemiology projects with relevance for safety and pharmacovigilance (natural history of disease, comorbidities, class effects, population health data, real-world drug safety monitoring, literature searches, signal detection and data mining, comparative effectiveness and safety research)&nbsp;</li>
<li>Ensure that all assigned activities are executed efficiently commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements</li>
<li>Provide medical safety strategy and execution of benefit-risk management strategies for assigned products</li>
<li>Provide safety input to clinical development plans, responses to HA or institutional review board/ ethics committee queries</li>
<li>Provide input into the development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development</li>
<li>Other duties as assigned</li>
</ul>
Ideal Candidate:
<ul>
<li>MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry (medical review of ICSRs and periodic reports)</li>
<li>A degree in epidemiology (Masters in Public Health, Masters of Science in Epidemiology, Doctor of Philosophy in Epidemiology, or Doctor of Public Health) or several years’ working knowledge in Epidemiology/Pharmacoepidemiology,) is highly preferred</li>
<li>Working experience / proficiency in Argus global safety database and medical review activities</li>
<li>Working experience in safety surveillance and signal detection activities&nbsp;</li>
<li>2-3 years Medical Device safety experience is a strong preference</li>
<li>Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above &nbsp;</li>
<li>Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies</li>
<li>Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions</li>
</ul>
What We Offer:
<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 &amp; 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>
The expected salary range offer for this role is $280,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;<div class="content-conclusion">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.
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.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div>

Director, Drug Safety Physician

<div class="content-intro">Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.</div>Role Summary:
The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices.
Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning.
Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP).
As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This individual will ensure compliance with applicable study protocols, SMPs, VOPs, SOPs, work instructions (WIs), study plans, contractual obligations, and established key performance indicators (KPIs).
This position reports to the Senior Vice President, Drug Safety and Pharmacovigilance.
Key Responsibilities:
Case Management and Safety Systems
<ul>
<li>Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.</li>
<li>Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.</li>
<li>Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.</li>
<li>Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.</li>
<li>Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.</li>
<li>Serve as the unblinded Drug Safety Operations representative, as required.</li>
</ul>
Vendor and Operational Governance
<ul>
<li>Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.</li>
<li>Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.</li>
<li>Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.</li>
<li>Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.</li>
<li>Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.</li>
</ul>
Safety Data, Surveillance, and Reporting
<ul>
<li>Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.</li>
<li>Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.</li>
<li>Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.</li>
<li>Support identification and evaluation of emerging safety concerns&nbsp;</li>
<li>Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.</li>
<li>Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.</li>
<li>Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.</li>
</ul>
Quality, Compliance, and Inspection Readiness
<ul>
<li>Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.</li>
<li>Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.</li>
<li>Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.</li>
<li>Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.</li>
<li>Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.</li>
</ul>
Systems, Documentation, and Business Continuity
<ul>
<li>Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.</li>
<li>Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.</li>
<li>Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.</li>
</ul>
Training
<ul>
<li>Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.</li>
<li>Oversee vendor training programs and monitor training completion and compliance.</li>
</ul>
Other
<ul>
<li>Perform other duties as assigned.</li>
</ul>
Ideal Candidate:
<ul>
<li>Master’s degree in relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) preferred</li>
<li>Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.</li>
<li>Hands-on experience with global safety databases, preferably Argus, and safety-data analytics.</li>
<li>Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management.</li>
<li>Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners.</li>
<li>Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements.</li>
<li>Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).</li>
<li>Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies</li>
<li>Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions </li>
</ul>
What We Offer:
<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 &amp; 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>
The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;<div class="content-conclusion">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.
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.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div>

Senior Director, Drug Safety and Pharmacovigilance Operations

<div class="content-intro">Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.</div>Role Summary:
We are seeking an experienced Associate Director, Clinical Supply Chain, to independently lead end-to-end supply for assigned global studies. This hands-on individual contributor will manage clinical demand and supply planning and execution. Global distribution will be a key focus, including country readiness, import and export execution, shipment tracking and issue resolution.&nbsp;
Working with a high degree of autonomy, this individual will influence cross-functional teams and partner closely with CMC, Clinical Operations, Quality, Regulatory, CROs, CDMOs, and other external providers to ensure uninterrupted, compliant, and cost-effective clinical supply.&nbsp;
Key Responsibilities:
Supply Chain Planning
<ul>
<li>Develop and maintain demand forecasts, supply plans, and scenario models using enrollment, dosing, randomization, manufacturing lead times, expiry, and inventory assumptions</li>
<li>Monitor inventory, expiry, and resupply across multiple depots and sites; evaluate changes and implement mitigation plans that balance supply continuity, cost, and inventory exposure</li>
<li>Support sourcing of comparator product and ancillary supplies, as required</li>
</ul>
Supply Chain Execution
<ul>
<li>Develop and maintain the clinical supply strategy for IRT systems, including user requirements, user acceptance testing, configuration review, and optimization of supply settings</li>
<li>Support review and approval of clinical supply documents, including label text, packaging specifications and batch records, pharmacy manuals, and applicable protocol, IND, and IMPD content</li>
<li>Collaborate with partners to establish packaging/labeling schedules to ensure continuous availability of clinical supplies</li>
</ul>
Global Distribution
<ul>
<li>Oversee external partners in executing global distribution for assigned studies, including depot-network strategy, inventory positioning, shipping lanes, country requirements, and contingency planning</li>
<li>Drive country activation from a clinical supply perspective and import-license readiness by maintaining country-specific requirements and readiness trackers, closing documentation gaps, and escalating risks before planned shipments</li>
<li>Review and coordinate import, export and customs documentation with CROs, CDMOs, Regulatory, importers of record, and other partners</li>
<li>Manage reverse logistics, including returns, reconciliation, recovery, and destruction, in accordance with protocol, quality, and country requirements</li>
<li>Build and monitor distribution metrics, including on-time delivery and right first time; use trends to improve processes and partner performance</li>
</ul>
Cross-Functional Leadership
<ul>
<li>Represent Clinical Supply Chain on study and program teams; lead supply discussions and communicate status, risks, tradeoffs, and recommendations to senior leaders and external partners</li>
<li>Establish scalable processes, templates, governance, and performance standards, and lead continuous improvement across clinical supply operations.</li>
</ul>
General Project Management
<ul>
<li>Maintain budget trackers, inventory and expiry dashboards, supply-risk reporting, KPIs, and vendor-performance metrics</li>
<li>Forecast costs, monitor budget versus actual spend, review proposals, change orders, and invoices, and identify cost risks and savings opportunities</li>
<li>Perform other duties as assigned</li>
</ul>
Ideal Candidate:
<ul>
<li>Bachelor’s degree in life sciences, supply chain, business, engineering, or a related field; an advanced degree is preferred</li>
<li>6-8+ years of progressive clinical supply chain and logistics experience, including at least 5 years directly managing global clinical supply</li>
<li>Demonstrated independent ownership of complex blinded global Phase 2 or Phase 3 studies involving multiple product presentations, and/or combination products and devices</li>
<li>Demonstrated hands-on ownership of global clinical trial distribution across multiple regions, including country activation, import-license readiness, import and export documentation, customs clearance, shipment execution</li>
<li>Advanced Excel skills and hands-on experience with clinical supply forecasting and optimization platforms (e.g. ERP) and IRT systems</li>
<li>Working knowledge of GMP, GDP, GCP, global import and export requirements, and applicable clinical supply regulations</li>
<li>Strong leadership presence and ability to influence cross-functional teams, senior stakeholders, and external partners without direct authority</li>
<li>Ability to assume ownership quickly with minimal onboarding and oversight, make risk-based decisions with incomplete information, manage competing priorities, and translate complex data into clear recommendations in a fast-paced environment</li>
<li>Highly organized and adaptable to change</li>
<li>Experience in a small biotechnology company, start-up, or similarly lean and rapidly evolving environment preferred</li>
</ul>
What We Offer:
<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 &amp; 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>
The expected salary range offer for this role is $175,000 to $198,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;<div class="content-conclusion">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.
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.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div>

Associate Director, Clinical Supply Chain

<div class="content-intro">Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.</div>Role Summary:
The Vice President, Clinical Development (Immunology &amp; Inflammation), reporting to the SVP of IBD Clinical Development, will provide strategic and operational leadership across Spyre's clinical portfolio of antibody therapeutics for IBD. This role is uniquely designed for a physician leader who thrives in a high-growth biotechnology environment and enjoys balancing long-term clinical development strategy with hands-on execution. The successful candidate will personally lead the ongoing Phase 2 platform study while helping to shape the future registrational program.
Key Responsibilities:
<ul>
<li>Clinical Leadership:&nbsp;
<ul>
<li>Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD. &nbsp;</li>
<li>Develop and continuously refine integrated clinical development plans aligned with corporate objectives, competitive landscape, and evolving scientific insights.</li>
<li>Serve as a hands-on study lead for the current platform trial as well as contribute to planning pivotal studies.</li>
<li>Personally contribute to protocol development, medical review, safety assessment, data interpretation, and study-level decision making for ongoing and future IBD clinical trials.</li>
<li>Support the efforts of the medical monitoring team which ensures timely responses to investigative sites, provides medical safety oversight, and supports the collection of high-quality, clinically robust data.</li>
</ul>
</li>
<li>Program Strategy &amp; Trial Execution:&nbsp;
<ul>
<li>Provide medical and scientific leadership for the design, conduct, analysis, and interpretation of clinical studies across all phases of development.</li>
<li>Lead protocol development, study conduct, data review, and interpretation for ongoing clinical trials, partnering closely with clinical operations, regulatory, biometrics, etc., to ensure successful execution.</li>
<li>Drive key development decisions through analysis of emerging clinical, translational, safety, and competitive data.</li>
<li>Chair or contribute to governance committees and cross-functional program teams.</li>
</ul>
</li>
<li>Cross-functional Collaboration:&nbsp;
<ul>
<li>Partner closely with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, Commercial, and Corporate Development teams to ensure coordinated execution of development strategies.</li>
<li>Promote a culture of scientific excellence, accountability, and collaboration.</li>
</ul>
</li>
<li>Regulatory Interface:&nbsp;
<ul>
<li>Lead clinical and medical strategy for regulatory interactions globally.</li>
<li>Serve as a primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and related responses.</li>
<li>Ensure development programs are conducted in compliance with global regulatory requirements and industry best practices.</li>
</ul>
</li>
<li>Safety Oversight:&nbsp;
<ul>
<li>Provide ongoing medical oversight of participant safety and benefit-risk assessments across assigned programs.</li>
<li>Review and interpret emerging safety data and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums.</li>
<li>Support signal detection, risk management planning, and clinical risk mitigation strategies.</li>
</ul>
</li>
<li>Leadership &amp; Mentorship:&nbsp;
<ul>
<li>Lead and mentor a high-performing clinical development team as the company grows.</li>
<li>Contribute broadly to corporate strategy, organizational planning, and leadership initiatives.</li>
<li>Other duties as assigned.</li>
</ul>
</li>
</ul>
Ideal Candidate:
<ul>
<li>MD or equivalent medical degree is required.&nbsp;</li>
<li>Minimum of 7+ years clinical development experience within the pharmaceutical or biotech industry, including substantial leadership experience in immunology, inflammation, or gastroenterology.</li>
<li>Training and/or experience in clinical development in gastroenterology or immunology &amp; inflammation is strongly preferred.</li>
<li>Demonstrated success leading mid- and late-stage clinical development programs.</li>
<li>Experience developing antibody therapeutics.&nbsp;</li>
<li>Experience leading complex, adaptive, umbrella, basket, or platform clinical trials is highly desirable.</li>
<li>Deep expertise in inflammatory bowel disease and/or other immune-mediated inflammatory disorders strongly preferred.</li>
<li>Significant experience with global regulatory interactions and submissions, including INDs, CTAs, briefing documents for global regulatory agencies.</li>
<li>Strong understanding of clinical trial design, biostatistics, translational medicine, drug development, and global regulatory requirements.</li>
<li>Demonstrated ability to influence strategy and drive cross-functional decision-making in a matrixed environment.</li>
<li>Demonstrated willingness and ability to remain personally engaged in study-level execution while simultaneously providing strategic leadership.</li>
<li>Strategic, entrepreneurial leader with the ability to balance long-term vision and hands-on execution in a fast-paced biotech environment. &nbsp; &nbsp; &nbsp; &nbsp;</li>
</ul>
What We Offer:
<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 &amp; 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>
The expected salary range offer for this role is $366,000 to $398,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;<div class="content-conclusion">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.
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.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div>

Get a job referral to Spyre Therapeutics

Description

Jobs· 7 open

About

Financials

Referrals