Executive Medical Director, Clinical Development
Spyre Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $365,000 - $396,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentclinical trial designbiostatisticsregulatory submissionsantibody therapeuticsimmunologyinflammation indicationssafety monitoringdata reviewGCP
Soft skills
strategic leadershipcommunication skillspresentation skillscollaborationmentoringoperational executionentrepreneurial mindsetclinical judgmentteam leadershipproblem-solving
Certifications
MDboard certification