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.
