Director / Sr. Director - Clinical Development

Akero Therapeutics, a Novo Nordisk company, is a clinical-stage biopharmaceutical organization developing transformational therapies for serious metabolic diseases. This role supports the Phase 3 clinical development of efruxifermin for MASH. The Director or Senior Director of Clinical Development leads trial execution, medical monitoring, regulatory documentation, and data interpretation while serving as a medical expert across internal teams and external stakeholders.

The Director or Senior Director of Clinical Development plays a key role in executing the Phase 3 clinical development program for efruxifermin, Akero Therapeutics’ lead investigational therapy for MASH. Reporting to the Vice President of Clinical Development, this position provides clinical leadership across trial execution, medical monitoring, data analysis, and regulatory support, while contributing to the upcoming BLA submission. The role collaborates closely with cross-functional teams and external partners to ensure high-quality, compliant clinical development activities.

Responsibilities:
- Plan, conduct, and evaluate ongoing Phase 3 clinical trials to ensure successful execution.
- Serve as Medical Monitor, reviewing safety and efficacy data and working with CRO partners.
- Support preparation of materials for clinical committees such as DMCs and adjudication committees.
- Author and review regulatory documents including protocols, CSRs, DSURs, and BLA components.
- Contribute to scientific publications, presentations, and data disclosures.
- Act as a clinical subject matter expert in internal and external meetings.

Requirements:
- Board-certified MD or MD/PhD or equivalent medical qualification.
- Minimum 3 years of clinical development experience; 5 years preferred.
- Direct experience with Phase III trials and medical monitoring.
- Strong knowledge of GCP, ICH, and FDA/EMA regulatory standards.
- Excellent communication, collaboration, and analytical skills.
- Experience in hepatology, MASH, or related fields preferred.

Benefits:
- Competitive base salary with bonus eligibility.
- Long-term incentive compensation.
- Comprehensive health, retirement, and insurance benefits.
- Flexible vacation and parental leave policies.

This role offers the opportunity to contribute to a pivotal clinical program addressing significant unmet medical need.