Senior Medical Director, Clinical Development
New
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Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeSenior
Salary$343,000 to $365,000
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Job Details
- Experience
- 4+ years clinical development experience
- Required Skills
- GCP
Requirements
- MD or equivalent medical degree.
- Minimum of 4+ years clinical development experience within the pharmaceutical or biotech industry.
- Experience within I&I indications, rheumatology strongly 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.
- Ability to manage complex projects in a fast-paced environment.
Responsibilities
- 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.
- 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.
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