Executive Medical Director, Clinical Development

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary:

The Executive Medical Director, Clinical Development (Immunology & Inflammation) will lead the execution of Spyre’s pioneering IBD studies evaluating the innovative pipeline of antibody therapeutics. Reporting to the SVP of Clinical Development, this individual will serve as a key clinical leader responsible for implementing clinical programs, ensuring scientific and medical rigor, and collaborating across functions to drive program success from early-stage development through late-phase trials. This is a highly visible role within a growing organization and will play a key role in directing research and formulating strategy to drive program success. 

Key Responsibilities:

• Clinical Leadership: Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD.  
• Program Strategy & Trial Execution: Design, plan, and oversee the execution of clinical studies, with a focus on proof-of-concept and later-stage development.
• Cross-functional Collaboration: partner with teams across Biostatistics, Regulatory Affairs, Development Operations, Translational Science, and other key functions to ensure cohesive and efficient program execution.
• Regulatory Interface: Contribute medical and scientific content for regulatory documents including INDs, Investigator Brochures, Clinical Study Reports, and regulatory submissions and responses. Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters. 
• Safety Oversight: Ensure participant safety through proactive safety monitoring, data review, and clinical judgment in response to emerging data.
• External Engagement: Serve as a primary medical representative for assigned programs, interfacing with investigators, academic experts, and key opinion leaders (KOLs).
• Leadership & Mentorship: Provide medical leadership within clinical teams and mentor as the organization grows.
• Other Responsibilities: Support strategic portfolio decisions and organizational initiatives as needed.

Ideal Candidate:    

• Education: MD or equivalent medical degree is required, board certification in a relevant specialty preferred.
• Experience & Skills:  
  • Minimum of 6+ years clinical development experience within the pharmaceutical or biotech industry, with significant experience in immunology and/or inflammation indications.
  • Experience with antibody therapeutics preferred. 
  • Demonstrated success in designing, executing, and interpreting IBD clinical trials.
  • Prior experience with regulatory submissions and interactions (e.g., INDs, CTAs, NDAs, BLAs).
  • Deep understanding of GCP, clinical trial design, biostatistics, and global regulatory expectations.
  • Excellent communication and presentation skills with the ability to collaborate effectively across scientific, operational, and executive teams.
  • Strategic mindset combined with strong operational execution capabilities.
  • Proven ability to thrive in a fast-paced, entrepreneurial 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 $365,000 to $396,000. 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, g