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Spyre Therapeutics · 3 hours ago

Executive Medical Director, Clinical Development

United States

Full-time

Remote

Director/Executive

$365K/yr - $396K/yr

6+ years exp

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. The Executive Medical Director, Clinical Development will lead the execution of IBD studies, ensuring scientific rigor and collaborating across functions to drive program success.

BiotechnologyTherapeutics

Responsibilities

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 compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters

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

Qualification

Clinical development experienceImmunology expertiseAntibody therapeutics experienceRegulatory submissions experienceGCP knowledgeClinical trial designBiostatistics understandingOperational executionCommunicationStrategic mindsetMentorship skills

Required

MD or equivalent medical degree is required

Minimum of 6+ years clinical development experience within the pharmaceutical or biotech industry

Significant experience in immunology and/or inflammation indications

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

Preferred

Board certification in a relevant specialty

Experience with antibody therapeutics

Benefits

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.