Director of Clinical Affairs

Job Summary

A company is looking for a Sr. Director of Clinical Affairs.

Key Responsibilities:

• Oversee strategic planning, execution, and management of clinical trials in gene therapy programs
• Ensure compliance with regulatory requirements and scientific standards in clinical studies
• Collaborate with cross-functional teams and external stakeholders for clinical trial success

Qualifications:

• Advanced degree in life sciences (PhD, PharmD) or related STEM field
• 8+ years of relevant experience in clinical research or clinical development
• Experience in designing and managing clinical trials from early to late-stage development
• In-depth knowledge of regulatory requirements (FDA, EMA, ICH/GCP)
• Experience in gene therapy and/or ophthalmology is preferred