Senior) Director of Clinical Development

About the Opportunity

We’ve been engaged by a publicly traded, clinical-stage biopharmaceutical company to find their next Senior Director, Clinical Development. Our client has pioneered a proprietary RNA interference platform now advancing clinical stage programs across four different therapy areas.

Our client is hiring a Senior Director, Clinical Development to help lead trial design, execution, and regulatory strategy across their growing pipeline. This is a high-visibility role reporting to the SVP of Clinical Development, with real ownership of a program from early clinical stages through pivotal trial design

• Lead clinical trial design and protocol development across Phase 1-3 studies
• Serve as a key point of contact for FDA interactions, including IND/NDA-enabling strategy and regulatory submissions
• Partner cross-functionally with regulatory affairs, biostatistics, clinical operations, and translational science
• Provide medical and scientific oversight of assigned clinical program(s)
• Engage externally with investigators, key opinion leaders, and clinical trial sites
• Help mentor and build out a growing clinical development team

• MD required; MD/PhD strongly preferred
• Significant experience in Phase 1-3 clinical trial design and execution within biotech/pharma
• Direct experience with FDA interactions and regulatory strategy
• Comfortable working cross-functionally across a diversifying pipeline - therapeutic area specialty matters less than demonstrated ability to lead clinical development from the ground up
• Based in or willing to relocate to the greater Boston area; able to work in-office a minimum of two days per week
• Strong communicator, able to operate autonomously while collaborating with global stakeholders