Spyre Therapeutics
Engineering for new heights in the treatment of inflammatory bowel disease
Executive Medical Director, Clinical Development
Location
United States
Posted
139 days ago
Salary
$365K - $396K / year
Professional Certificate6 yrs expEnglishGoogle Cloud Platform
Job Description
• Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD.
• Design, plan, and oversee the execution of clinical studies, with a focus on proof-of-concept and later-stage development.
• Partner with teams across Biostatistics, Regulatory Affairs, Development Operations, Translational Science, and other key functions to ensure cohesive and efficient program execution.
• Contribute medical and scientific content for regulatory documents including INDs, Investigator Brochures, Clinical Study Reports, and regulatory submissions and responses.
• Ensure participant safety through proactive safety monitoring, data review, and clinical judgment in response to emerging data.
• Serve as a primary medical representative for assigned programs, interfacing with investigators, academic experts, and key opinion leaders (KOLs).
• Provide medical leadership within clinical teams and mentor as the organization grows.
• Support strategic portfolio decisions and organizational initiatives as needed.
Job Requirements
- Education: MD or equivalent medical degree is required, board certification in a relevant specialty preferred.
- 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.
Benefits
- 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 year
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
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