Clinical Affairs Director

Job Summary

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

Key Responsibilities:

• Oversee strategic planning, execution, and management of clinical trials for gene therapy programs
• Ensure compliance with regulatory requirements and collaborate with cross-functional teams
• Lead clinical data analysis and ensure timely preparation of key documents for regulatory submissions

Qualifications:

• Advanced degree in life sciences (PhD, PharmD) or related STEM field
• 8+ years of experience in clinical research or development in the pharmaceutical or biotech industry
• Experience in designing and executing clinical trials from early-stage to late-stage studies
• Strong understanding of gene therapy, rare diseases, and relevant regulatory requirements
• Proven leadership skills and ability to influence key stakeholders effectively