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Spyre Therapeutics

Vice President, Clinical Development

RemoteUnited States only
Published
Role
Research
Experience
Senior
Company size
Startup
$366k–$398k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Physician clinical development leader with 7+ years in pharma/biotech and strong immunology, inflammation, gastroenterology, or IBD experience. Must have led mid- and late-stage clinical programs, global regulatory interactions, and antibody therapeutics development. US remote role with frequent in-person meetings.

What you'll do

  • Provide strategic leadership and medical expertise for the clinical development of the 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 and 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 medical monitoring team in timely responses to investigative sites, medical safety oversight, and collection of high-quality, clinically robust data.
  • 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.
  • Partner closely with clinical operations, regulatory, biometrics, and other functions to ensure successful trial 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.
  • Partner with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, Commercial, and Corporate Development teams to coordinate execution of development strategies.
  • Promote a culture of scientific excellence, accountability, and collaboration.
  • 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.
  • 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.
  • 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.

What they require

  • 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 agencies.
  • Strong understanding of clinical trial design, biostatistics, translational medicine, drug development, and global regulatory requirements.
  • Demonstrated ability to influence strategy and drive cross-functional decision-making in a matrixed environment.
  • Demonstrated willingness and ability to remain personally engaged in study-level execution while simultaneously providing strategic leadership.
  • Strategic, entrepreneurial leader with the ability to balance long-term vision and hands-on execution in a fast-paced biotech environment.

Benefits

  • Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of a young company, contribute broadly to advance meaningful medicines, and learn quickly.
  • Market competitive compensation and benefits package.
  • Base salary.
  • Performance bonus.
  • Equity grant opportunities.
  • Health benefits.
  • Welfare benefits.
  • Retirement benefits.
  • Unlimited PTO.
  • Two, one-week company-wide shutdowns each year.
  • Commitment to provide professional development opportunities.
  • Remote working environment with frequent in-person meetings to address complex problems and build relationships.

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.

BiotechStartupspyre.com

Details

Apply routeGreenhouse
$366k–$398k/yr