Director of Clinical Development, Biotech (Hybrid Boston)

Scovai; Boston (MA); Hybrid; USD 300.000 - 450.000; Vollzeit

Zusammenfassung

Scovai, based in Boston, is conducting a confidential search for a Director of Clinical Development to lead clinical development programs in a hybrid setting. The role centers on designing and executing trial strategies across multiple therapies and aligning regulatory submissions to product approvals.

The successful candidate will manage cross-functional operations, CRO, and external partners, mentor a growing team, and drive budgets, timelines, and resource planning to shape the company's

Qualifikationen

• Directs clinical development programs across phases and therapeutic areas.
• Ensures compliance with GCP/ICH and regulatory requirements.
• Leads interactions with FDA/EMA and regulatory submissions.
• Manages budgets, timelines, and resource allocation for programs.
• Mentors and develops a high-performing clinical development team.

Aufgaben

• Define and execute the clinical development strategy from Phase I through registration.
• Oversee trial design, protocol development, and study execution across multiple therapies.
• Lead interactions with regulatory authorities and manage IND/NDA/BLA submissions.
• Collaborate with translational science, medical affairs, and commercial teams to align programs.
• Mentor and develop a high-performing clinical development team.

Kenntnisse

Clinical development leadership

Regulatory submissions

Cross-functional leadership

Budget & resource planning

Jobbeschreibung

Scovai, based in Boston, is conducting a confidential search for a Director of Clinical Development to lead clinical development programs in a hybrid setting. The role centers on designing and executing trial strategies across multiple therapies and aligning regulatory submissions to product approvals.

The successful candidate will manage cross-functional operations, CRO, and external partners, mentor a growing team, and drive budgets, timelines, and resource planning to shape the company's