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 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.
What We Offer:
- 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.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
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.
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/.