Vice President, Clinical Development

About this role

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.

Role Summary:

The Vice President, Clinical Development (Immunology & 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:

• Clinical Leadership:

• Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD.

• Develop and continuously refine integrated clinical development plans aligned with corporate objectives, competitive landscape, and evolving scientific insights.

• Serve as a hands-on study lead for the current platform trial as well as contribute to planning pivotal studies.

• Personally contribute to protocol development, medical review, safety assessment, data interpretation, and study-level decision making for ongoing and future IBD clinical trials.

• 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.

• Program Strategy & Trial Execution:

• Provide medical and scientific leadership for the design, conduct, analysis, and interpretation of clinical studies across all phases of development.

• 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.

• Drive key development decisions through analysis of emerging clinical, translational, safety, and competitive data.

• Chair or contribute to governance committees and cross-functional program teams.

• Cross-functional Collaboration:

• 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.

• Promote a culture of scientific excellence, accountability, and collaboration.

• Regulatory Interface:

• Lead clinical and medical strategy for regulatory interactions globally.

• Serve as a primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and related responses.

• Ensure development programs are conducted in compliance with global regulatory requirements and industry best practices.

• Safety Oversight:

• Provide ongoing medical oversight of participant safety and benefit-risk assessments across assigned programs.

• Review and interpret emerging safety data and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums.

• Support signal detection, risk management planning, and clinical risk mitigation strategies.

• Leadership & Mentorship:

• Lead and mentor a high-performing clinical development team as the company grows.

• Contribute broadly to corporate strategy, organizational planning, and leadership initiatives.

• Other duties as assigned.

Ideal Candidate:

• MD or equivalent medical degree is required.

• Minimum of 7+ years clinical development experience within the pharmaceutical or biotech industry, including substantial leadership experience in immunology, inflammation, or gastroenterology.

• Training and/or experience in clinical development in gastroenterology or immunology & inflammation is strongly preferred.

• Demonstrated success leading mid- and late-stage clinical development programs.

• Experience developing antibody therapeutics.

• Experience leading complex, adaptive, umbrella, basket, or platform clinical trials is highly desirable.

• Deep expertise in inflammatory bowel disease and/or other immune-mediated inflammatory disorders strongly preferred.

• Significant experience with global regulatory interactions and submissions, including INDs, CTAs, briefing documents for global regulatory…