Executive Medical Director, Clinical Development

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.

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.

Qualifications

• 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.

Skills

• Strategic medical leadership in clinical development
• Clinical study design and execution for immunology/inflammation programs
• Regulatory documentation and IND/CTAs/NDAs/BLAs interactions
• Regulatory compliance and GCP knowledge
• Cross-functional collaboration and stakeholder management
• Communication and presentation to scientific, operational, and executive audiences

Education

• MD or equivalent medical degree
• Board certification in a relevant specialty preferred

Additional Requirements

• Experience in fast-paced, entrepreneurial environments