Associate Director Clinical Operations

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 (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Ascentage Pharma is proud of its collaborative and supportive culture, unified by a shared desire to develop therapeutics that will have a positive impact on patients’ lives. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history. The company is defined by a shared understanding that it succeeds in advancing its mission only as each experience’s success in their role. Following our recent IPO on NASDAQ, we are expanding our U.S. leadership team to support financial compliance, reporting rigor, and scalable growth in a complex, multinational environment.

role.

Position Summary - Associate Director, Clinical Operations

The Associate Director of Clinical Operations leads the operational strategy, planning, and end-to-end execution of the company's global late-stage (Phase 2/3) clinical programs. This individual will drive studies from protocol concept through to New Drug Application (NDA) submissions and global regulatory filings. Acting as a core foundational pillar for the clinical department, they oversee complex programs across oncology and hematologic malignancies, spanning advanced modalities including CAR-T, small molecules, and biologics. This role directly manages a dedicated team of operational direct reports to ensure data integrity, strict ICH-GCP compliance, and clinical inspection readiness.

Key Responsibilities

• Late-Stage Program Execution: Lead the operational planning, execution, and close-out of global, registrational Phase 2 and Phase 3 clinical trials.
• Regulatory & NDA Submission Drive: Deliver operationally sound data pipelines to support IND/NDA filings, actively participating in clinical overview drafting, regulatory response workflows, and marketing authorization applications.
• Therapeutic Modality Strategy: Design targeted operational strategies tailored to complex oncology and hematology protocols, including specialized operational, manufacturing, and chain-of-custody workflows required for CAR-T, small molecules, and biologics.
• People Management & Leadership: Provide direct oversight, mentorship, and career development to a growing team of direct reports, including Clinical Trial Managers (CTMs) and regional study monitors.
• CRO & Vendor Governance: Direct selection, contracting, and relationship management for global Contract Research Organizations (CROs) and specialized vendors, holding partners strictly accountable to key performance metrics.
• Cross-Functional Collaboration: Partner seamlessly with Clinical Development, Regulatory Affairs, CMC, Biostatistics, Data Management, and Drug Supply to maintain structural alignment across the drug development pipeline.
• Inspection Readiness: Maintain a continuous state of audit and inspection readiness, ensuring all trials strictly comply with FDA regulations, ICH-GCP guidelines, and international country-specific laws.
• Financial & Risk Management: Own program-level budget forecasting, tracker allocation, financial milestones, and proactive risk mitigation strategies.

Requirements & Qualifications

• Education: Bachelor’s degree in a Life Sciences, BSN or scientific discipline is required. An advanced degree (e.g., MS, MSN, PhD, PharmD) is highly preferred.
• Industry Experience: A minimum of 8–10 years of progressive clinical operations experience within a biotechnology, pharmaceutical, or clinical research organization (CRO).
• Trial Lifecycle Expertise: At least 4+ years of independent trial management experience, showing a clear history of steering global programs completely from early planning stages through database lock and submission windows.
• Therapeutic Depth: Proven operational expertise managing clinical trials in oncology; direct experience managing protocols for hematologic malignancies (leukemia, lymphoma, myeloma) is required.
• Technical Modality Track Record: Strong, demonstrable experience working on trials utilizing CAR-T / cell therapies, small molecules, and biologics.
• Leadership Capability: Proven experience as a people manager with direct reports, with a track record of successfully coaching and scaling clinical operations personnel.
• Submission Track Record: Direct, hands-on experience supporting operational milestones for successful NDA, BLA, or major global regulatory submissions.
• Work Logistics: Ability to work efficiently in a fully remote environment, with a strong preference for candidates located within the Eastern Time Zone (EST) to optimize cross-functional team collaboration.

Why Join Us- Our Value Proposition

This is a rare opportunity to shape the clinical vision of a public biotech at a pivotal growth moment—and see your work make a tangible impact for patients. If you want to do something that matters—this work matters. Patients drive our passion to pioneer novel cancer therapies. Creating and delivering life-changing medicines requires focus, dedication, and heart. We hire exceptional people, trust them to do their best work, and support them with the resources and flexibility to thrive.

What We Offer

• Exciting, supportive, and intellectually challenging global work environment.
• Competitive benefits, including medical, dental, vision, disability, and life insurance, parental leave, and a matching 401(k) program (immediate vesting).
• Generous PTO and holidays encourage balance and recharge.
• A culture of engagement, diversity, inclusion, and empowerment.
• Flexibility to work onsite, remotely, or in a hybrid model.

Compensation and Benefits

At Ascentage, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity, and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity.