Senior Medical Director, Clinical Development Dermatology
New
S
Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeSenior
Salary$343,000 to $365,000
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Job Details
- Experience
- 4+ years
- Required Skills
- GCP
Requirements
- MD/DO or equivalent medical degree.
- Board-certified dermatologist (strongly preferred).
- Minimum of 4+ years clinical development experience within the pharmaceutical or biotech industry.
- Experience within immunology and inflammation (I&I) indications.
- Experience in Dermatology (Hidradenitis suppurativa) (strongly preferred).
- Experience with antibody therapeutics (preferred).
- Proven track record in designing and executing clinical trials in I&I indications.
- 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 an antibody portfolio in dermatologic indications.
- Lead day-to-day execution and data read-outs for ongoing Phase 2 programs.
- Contribute to the overall development strategy, program design, and execution of pivotal development programs.
- Collaborate with Biostatistics, Regulatory Affairs, and Clinical Operations for integrated trial design.
- Provide scientific and medical content for INDs, Investigator Brochures, and regulatory submissions.
- Ensure safety of study participants through active safety monitoring and data review.
- Represent Clinical Development in interactions with regulatory agencies, investigators, and KOLs.
- Lead development of study-related publications and conference presentations.
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