Director of Clinical Development — Biotechnology

We are conducting a confidential search for a Director of Clinical Development to lead clinical development programs within a leading biotechnology organization. This is a high-impact, director-level opportunity based in Boston on a hybrid model for a seasoned clinical leader with deep expertise in designing and executing clinical trial strategies, managing cross-functional clinical operations, and driving regulatory submissions to support product approvals.

In this role, you will define and execute the clinical development strategy for the biotechnology pipeline, from Phase I through registration. You will oversee clinical trial design, protocol development, and study execution across multiple therapeutic areas. You will lead interactions with regulatory authorities (FDA, EMA) and manage IND/NDA/BLA submissions. You will build and manage relationships with CROs, academic partners, and key opinion leaders while ensuring compliance with GCP/ICH guidelines and all applicable regulatory requirements.

You will collaborate with translational science, medical affairs, and commercial teams to align clinical programs with business objectives, manage clinical development budgets, timelines, and resource allocation, and mentor and develop a high-performing clinical development team. This is a rare opportunity to shape the clinical trajectory of a growing biotechnology enterprise.

Nice to Have:

• Experience in oncology, rare diseases, or gene/cell therapy clinical programs
• Published clinical research or regulatory submissions in peer-reviewed journals
• Experience with adaptive trial designs and decentralized clinical trials
• Familiarity with real-world evidence and post-market clinical studies
• Global clinical development experience across US, EU, and APAC regions

Nice to have

• Experience with rare disease or orphan drug development
• Prior interaction with FDA Breakthrough Therapy or Accelerated Approval pathways
• Background in cell & gene therapy or mRNA platforms
• Experience leading global multi-site clinical trials
• Publications in peer-reviewed clinical journals