Associate Director, Clinical Research

The Associate Director, Clinical Research will be responsible for managing and executing various aspects of clinical studies, including site selection, patient recruitment, vendor oversight, and tracking clinical data. The role will involve working with global project teams, NS Pharma Japan (HQ), external partners, and vendors. The Associate Director will be responsible for ensuring compliance with relevant regulations, including FDA, ICH, and regulatory requirements.

What You Will Do

The main day-to-day responsibilities will include planning, implementing, and managing regional or global clinical studies; managing and leading the selection process of CROs; managing the performance of study vendors; coordinating and collaborating with the Clinical Lead to achieve project objectives; and managing project performance issues.

Why It Might Be a Fit

The ideal candidate will have experience in negotiating Master Service Agreements, Project Specific Contracts, and Budgets. They will be able to work effectively in a multi-cultural, global team environment and have a thorough understanding of clinical operations involved in planning, launching, and closing clinical studies.

Requirements

• Bachelor’s Degree in sciences or related field
• 8+ years of pharmaceuticals/biotech experience
• Certified Project Management Professional (PMP) preferred
• Minimum of 8+ years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience
• Hematology - oncology clinical trial experience preferred
• Rare Disease experience preferred
• Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.)
• Program and project management experience preferred

Benefits

• Medical, Dental & Vision Insurance
• Basic and Voluntary Life and AD&D Insurance
• Short- and Long-Term Disability Insurance
• Flexible Spending Account
• Health Savings Account
• Employee Assistance Programs
• Discretionary Bonus Programs
• Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off
• Sick Time
• Paid Holidays
• Paid Year-End Shutdown
• Career Development, Progression and Training
• Flexible Work Arrangement Programs