Associate Director, Clinical Operations (SF Bay Area)

Structure Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead Clinical Operations to direct all phases of the company's clinical development, focusing on cardiovascular, metabolic, and pulmonary indications. You will drive study planning, vendor management, regulatory documentation, and global trial execution.

You bring 8+ years in biotech/pharma CROs, expert ICH-GCP knowledge, and a track record of multi-site Phase I-III leadership. This remote role requires up to 20% travel and strong cross-functional leadership.

Qualifications

• Bachelor's degree in a scientific or health discipline.
• 8+ years in clinical operations within biotech/pharma/CRO.
• Proven experience managing Phase I-III trials, start-up activities, and global/multi-site studies.
• Strong knowledge of ICH-GCP, FDA, EMA regulations.
• Experience with Asia-Pacific regions preferred.

Responsibilities

• oversee study planning, vendor management, regulatory documentation, risk mitigation, and cross-functional collaboration
• manage budgets, timelines, and study execution
• lead site and investigator engagement
• ensure GCP compliance and data integrity
• mentor clinical operations staff

Skills

leadership

vendor oversight

strategic planning

regulatory acumen

excellent communication

problem solving

team management

Education

Bachelor's degree in science/health

Job description

Role

Lead clinical operations for all phases of the company's clinical development pipeline, focusing on cardiovascular, metabolic, and pulmonary indications.

Responsibilities

• oversee study planning, vendor management, regulatory documentation, risk mitigation, and cross-functional collaboration
• manage budgets, timelines, and study execution
• lead site and investigator engagement
• ensure GCP compliance and data integrity
• mentor clinical operations staff

Requirements

• Bachelor's degree in a scientific or health discipline
• 8+ years in clinical operations within biotech/pharma/CRO
• proven experience managing Phase I-III trials, start-up activities, and global/regional multi-site studies
• strong knowledge of ICH-GCP, FDA, EMA regulations
• experience with Asia-Pacific regions preferred

Skills

leadership, vendor oversight, strategic planning, regulatory acumen, excellent communication, problem-solving, and team management.

High-Value

expertise in clinical trial management, cross-cultural team coordination, multi-regional trial oversight, and compliance in a global biotech setting.

WorkSetup

remote with up to 20% travel.