(Senior) Director of Clinical Development

Apsida Life Science; Massachusetts; Hybrid; USD 180,000 - 260,000; Full time

Job summary

Apsida Life Science in the greater Boston area is seeking a Senior Director, Clinical Development to lead trial design, execution, and regulatory strategy across a growing pipeline. This high-visibility role reports to the SVP of Clinical Development and offers ownership of a program from early clinical stages through pivotal trial design.

The ideal candidate is MD (MD/PhD preferred) with significant Phase 1-3 trial experience, FDA interactions, and the ability to lead cross-functionally with

Qualifications

• MD or equivalent medical degree; MD/PhD preferred.
• Extensive experience in Phase 1–3 trial design and execution.
• Direct experience with FDA interactions and regulatory strategy.
• Ability to lead cross-functionally across regulatory affairs, biostatistics, and operations.

Responsibilities

• Lead trial design and protocol development across Phase 1–3.
• Serve as primary contact for FDA interactions and regulatory submissions.
• Mentor clinical development team and collaborate with global stakeholders.
• Oversee execution of clinical programs from early to pivotal stages.

Skills

Trial design

Regulatory strategy

Cross-functional leadership

FDA interactions

Education

MD

MD/PhD preferred

Job description

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.

The Role

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

Key Responsibilities

• 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

Who You Are

• 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