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Role Overview:
- You will serve as a key member of the clinical development team, reporting to the VP Clinical Development.
- You will contribute to the execution of the Phase 3 clinical program for Efruxifermin (EFX).
Key Responsibilities:
- Serve as Medical Monitor, conducting ongoing review of emerging medical/safety data and working closely with CRO partners.
- Plan, conduct, and evaluate clinical trials, including preparation for trial-related committees.
- Author and critically review regulatory documents and scientific disclosures.
Qualifications:
- Board Certified MD or MD/PhD with relevant medical experience in hepatology or internal medicine.
- Minimum 3 years of clinical development experience in biotech/pharma, with direct experience in medical monitoring of clinical trials.
- Strong knowledge of GCP, ICH guidelines, and FDA/EMA regulations.
Benefits:
- Comprehensive medical, dental, and vision coverage.
- 401(k) savings plan with company contributions.
- Flex-able vacation policy and parental leave.
Akero Therapeutics
Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They foster a collaborative culture among a diverse team of problem solvers.