Executive Medical Director, Clinical Development

October 28

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Spyre Therapeutics

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Biotechnology • Pharmaceuticals

Spyre Therapeutics is a biopharmaceutical company focused on developing therapies for Inflammatory Bowel Disease (IBD). The company is committed to creating best-in-class antibodies, rational therapeutic combinations, and employing precision immunology approaches to enhance treatment efficacy and convenience for IBD patients. With a team experienced in developing and commercializing treatments across various diseases, Spyre Therapeutics is dedicated to improving treatment options and outcomes for patients through advanced research in immunology. The company fosters a collaborative and innovative environment to achieve its mission of providing promising new treatment options for IBD.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 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.

🎯 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.