Senior Director, Clinical Research & Development

Responsibilities

• Provide clinical evaluation of external molecules during Due Diligence
• Contribute to cross-functional planning for molecules from discovery platforms
• Participate in transition teams for in-licensed or acquired molecules
• Oversee clinical execution and development planning
• Maintain awareness of scientific developments and competitive landscapes

Qualifications

• MD, MD/PhD, PharmD or equivalent medical training required
• At least 7 years of clinical development experience in biotech or pharmaceutical settings
• Experience with oral small molecules and biologics; combination drug-device experience preferred
• Original NDA, MAA, and J-NDA experience is essential
• In-depth understanding of global regulatory pathways, including FDA, EMA, and PMDA

Benefits

• Comprehensive medical, dental, and vision coverage
• Generous paid time off policies with family-forming benefits
• 401(k) plan with competitive company match
• Access to a Company Learning Institute for professional growth
• Employee resource groups and volunteer opportunities