Vice President, Clinical Development

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:

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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.

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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.

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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.

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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.

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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.

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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 experien