Director of Early-Phase Clinical Development Operations

Scorpion Therapeutics; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics in Boston seeks Associate Director or Director of Clinical Development Operations to oversee early-phase programs (Phase 1/2) in biopharma, focusing on innovative treatments for serious diseases. The role requires leading study start-up, execution, vendor and site oversight, data quality, and regulatory compliance.

You will collaborate with multidisciplinary teams on trial design, operational planning, and regulatory milestones, manage budgets and timelines, and develop

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years industry experience with at least 5 years in clinical trial management.
• Experience in early-phase (FIH, IND/CTA) studies and global, multi-site trials.
• Strong knowledge of ICH-GCP, FDA, EMA regulations.
• Proficiency with clinical systems (EDC, CTMS, TMF).
• Excellent cross-functional collaboration skills.
• Experience in metabolic diseases, obesity, oncology, or rare diseases preferred.

Responsibilities

• Lead end-to-end clinical trial management across start-up, execution, vendor and site oversight.
• Collaborate with cross-functional teams on trial design, planning, and regulatory milestones.
• Manage budgets and timelines for early-phase programs.
• Develop essential clinical documentation and contribute to process improvements.

Skills

Cross-functional collaboration

Regulatory compliance

Clinical trial management

Vendor management

Leadership

Education

Bachelor's degree in life sciences

Tools

EDC

CTMS

TMF

Job description

Scorpion Therapeutics in Boston seeks Associate Director or Director of Clinical Development Operations to oversee early-phase programs (Phase 1/2) in biopharma, focusing on innovative treatments for serious diseases. The role requires leading study start-up, execution, vendor and site oversight, data quality, and regulatory compliance.

You will collaborate with multidisciplinary teams on trial design, operational planning, and regulatory milestones, manage budgets and timelines, and develop