Associate Director, Clinical Study Lead

Scorpion Therapeutics; Boston (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior-level Clinical Study Lead to oversee global clinical studies, ensuring timely, compliant, and quality-driven delivery. You will lead study planning, start-up, execution, and close-out with cross-functional coordination and vendor oversight.

Key responsibilities include risk mitigation, regulatory compliance (ICH-GCP, FDA, EMA), and management of outsourced models. Travel and flexible work arrangements are likely given global scope.

Qualifications

• Bachelor's degree in life sciences or related field.
• 7+ years in pharma, biotech, or CRO with at least 6 years in clinical research.
• Experience managing outsourced models, CRO oversight, and regulatory compliance (ICH-GCP, FDA, EMA) essential.

Responsibilities

• Study planning, start-up, execution, and close-out.
• Vendor management and monitoring.
• Risk mitigation and regulatory compliance oversight.

Skills

Project management

Risk assessment

Cross-cultural communication

Problem solving

Education

Bachelor's degree in life sciences

Job description

Role:

Senior-level Clinical Study Lead responsible for operational oversight of global clinical studies within specified regions, ensuring timely, compliant, and quality-driven delivery.

Responsibilities:

Responsibilities include study planning, start-up, execution, vendor management, monitoring, risk mitigation, and study close-out, with a focus on cross-functional coordination, regulatory compliance, and vendor oversight.

Qualifications:

Bachelor's degree in life sciences or related field; 7+ years in pharma, biotech, or CRO with at least 6 years in clinical research, including Phase 1-3 studies management. Experience managing outsourced models, CRO oversight, and regulatory compliance (ICH-GCP, FDA, EMA) essential.

Skills:

Strong project management, risk assessment, global cross-cultural communication, and problem-solving capabilities.

High-Value:

Experience leading regional/global studies, managing CRO/vendor relationships, working within regulated environments, and traveling domestically and internationally.

WorkSetup:

Not specified, but involvement in global studies implies flexible, possibly hybrid or remote work with travel.