Remote Associate Director, Clinical Operations (Late-Stage)

Ascentage Pharma; United States; Remote; USD 170,000 - 250,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with employer match

Remote/hybrid work flexibility

Job summary

Ascentage Pharma seeks an Associate Director of Clinical Operations to lead global late-stage programs (Phase 2/3), from protocol concept to NDA submissions, across oncology and hematologic malignancies.

You will supervise a team of CTMs and regional monitors, govern CROs, ensure ICH-GCP compliance, and partner with regulatory, CMC, Biostatistics, and Drug Supply to drive submissions and inspections.

Qualifications

• 8–10 years of progressive clinical operations experience in biotech/pharma/CRO.
• At least 4+ years of independent trial management handling global programs.
• Experience managing oncology trials including hematologic malignancies.

Responsibilities

• Lead operational planning, execution, and close-out of Phase 2/3 global trials.
• Drive IND/NDA filings with data pipelines and regulatory response support.
• Design operational strategies for CAR-T, small molecules, and biologics.
• Mentor and scale a team of CTMs and regional study monitors.
• Govern CROs and vendors with KPIs to ensure compliance and quality.

Skills

People management

Regulatory submissions support

Cross-functional collaboration

Budget forecasting

ICH-GCP compliance

Education

Bachelor’s degree in Life Sciences

Advanced degree (MS/MSN/PhD/PharmD)

Job description

Ascentage Pharma seeks an Associate Director of Clinical Operations to lead global late-stage programs (Phase 2/3), from protocol concept to NDA submissions, across oncology and hematologic malignancies.

You will supervise a team of CTMs and regional monitors, govern CROs, ensure ICH-GCP compliance, and partner with regulatory, CMC, Biostatistics, and Drug Supply to drive submissions and inspections.