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Spyre Therapeutics

Senior Medical Director, Clinical Development

RemoteUnited States only
Published
Experience
Senior
Employment
Full-time
Company size
Startup
$343k–$365k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior clinical development physician for rheumatology/immunology programs, with MD or equivalent and 4+ years in pharma/biotech clinical development. Must know clinical trial design, GCP, regulatory filings, statistics, and global regulatory processes; antibody therapeutics experience is preferred. US remote role.

What you'll do

  • Contribute strategic leadership and medical expertise to the clinical development of our cutting-edge antibody portfolio in rheumatic indications.
  • Contribute to the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development.
  • Work closely with cross-functional teams including Biostatistics, Regulatory Affairs, and Clinical Operations to support integrated and strategic trial execution.
  • Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters.
  • Ensure the safety of study participants by actively participating in safety monitoring and data review processes.
  • Represent the Clinical Development function in interactions with regulatory agencies, investigators, KOLs, and other external stakeholders, as appropriate.
  • Other activities as required.

What they require

  • MD or equivalent medical degree is required.
  • Minimum of 4+ years clinical development experience within the pharmaceutical or biotech industry within I&I indications, rheumatology strongly preferred.
  • Preferred: Experience with antibody therapeutics preferred.
  • Proven track record in designing and executing clinical trials in immunology or inflammation.
  • Experience with regulatory filings and interactions with health authorities.
  • Strong understanding of GCP, clinical trial design, statistics, and global regulatory processes.
  • Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
  • Ability to manage complex projects in a fast-paced 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
  • Commitment to provide professional development opportunities.
  • Remote working environment with frequent in-person meetings to address complex problems and build relationships.

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

BiotechStartupspyre.com

Details

Apply routeGreenhouse
$343k–$365k/yr