Senior Director Clinical Development – Early Development Team Leader (EDTL)

We are seeking a Senior Director, Clinical Development to lead our Early Development Team (EDT) and oversee the successful delivery of development milestones, including IND, FIH, POC, EOP2 and NDA. The role will include responsibility for designing and conducting FIH and proof of concept studies for new molecules, leading global teams, and supporting the development and writing of regulatory documents.

Requirements

• Minimum of 15 years of industry experience (Pharmaceutical, Biotech or related field)
• Minimum of 10 years of hands-on experience: Developing a clinical development plan after deep understanding and evaluation of nonclinical data, CMC, regulatory, marketing and clinical operations;
• Minimum of 5 years of hands-on experience: leading a global team for clinical development including non-clinical, clinical, data science, regulatory and CMC staff;
• Designing/writing phase 1 and 2 clinical study protocols, and comfortable with supporting the writing of sections from IB/IND/CTA or other regulatory dossiers as needed;

Benefits

• Medical/Dental
• Life Insurance
• Supplemental Life Insurance/Dependent Life Insurance
• Accidental Death & Dismemberment Insurance
• Business Travel Accident Insurance
• Short-Term Disability
• Long-Term Disability
• Flexible Spending Accounts
• Employee’s Savings Plan (401K Plan)
• Competitive Paid Time Off