Job Description

WHO WE ARE:

Ascentage Pharma is a globally-focused, clinical-stage biopharmaceutical company with a robust portfolio of assets across multiple therapeutic areas. Recently listed on Nasdaq (AAPG), our expertise is in developing novel small molecule therapies for cancers, hepatitis B, and age-related diseases. Located in the USA, China, UK and Australia, we are leveraging our expertise in structure-based drug design and our innovative drug discovery engine.

Job Description Summary: Clinical Trial Manager, Oncology

Location: Remote ( strong preference for candidates based in the Washington, DC metro area)

The Clinical Trial Manager (CTM) leads the planning, execution, and oversight of Phase I–II clinical trials to ensure adherence to timelines, budgets, and regulatory requirements (FDA, GCP, ICH). This role manages vendor and CRO partnerships, ensures quality and compliance, and supports key clinical operations deliverables from protocol development through study close-out.

What You’ll Do

• Lead the planning, execution, and day-to-day management of Phase I–II oncology clinical trials, partnering with CROs and vendors to ensure high-quality delivery on time and within budget.
• Serve as a primary operational point of contact for assigned studies, with increasing ownership across the full trial lifecycle—from protocol development through database lock and clinical study report.
• Manage CRO and vendor performance, including timelines, deliverables, and quality standards; contribute to RFP development and vendor selection.
• Oversee clinical trial documentation and ensure Trial Master File (TMF) completeness and continuous audit readiness.
• Partner cross-functionally with Clinical Development, Regulatory, Data Management, Quality, and external stakeholders to ensure compliant trial conduct in accordance with FDA/EU regulations and GCP/ICH guidelines.
• Track study timelines, enrollment progress, and milestones; proactively identify risks and implement mitigation strategies, escalating strategically when needed.
• Support investigational site identification and selection and maintain effective relationships with investigators, CRAs, and site personnel.
• Contribute to study budgets and provide clear, concise updates on trial progress to internal stakeholders and leadership.

What You Bring

• Bachelor’s or Master’s degree in life sciences, nursing, or a related field (or equivalent experience).
• 6+ years of clinical operations experience, including 5+ years managing clinical trials within a biotech or pharmaceutical environment.
• Hands-on experience with Phase I–II oncology trials strongly preferred.
• Strong project management and CRO/vendor oversight skills, with the ability to manage complex timelines and competing priorities.
• Solid understanding of global clinical trial regulations, GCP/ICH guidelines, and IND safety reporting.
• Experience maintaining TMFs and supporting audit and inspection readiness.
• Demonstrated ability to operate with a high degree of autonomy while remaining highly collaborative in a matrixed environment.
• Strong communication skills and executive presence appropriate for interaction with senior internal and external stakeholders.

Career Growth & Impact

This is a Clinical Trial Manager role with meaningful stretch and visibility. At Ascentage, CTMs are trusted partners in trial execution and are encouraged to expand their scope as programs progress. You’ll gain exposure to complex oncology studies, increased cross-functional leadership, and opportunities to take on broader responsibilities as the organization and pipeline grow—positioning you well for future advancement while remaining grounded in hands-on clinical trial leadership.

Culture

At Ascentage Pharma, we strive to create a culture based on personal and professional growth and opportunity, focusing on these principles:

• Establish a collaborative, energized and fun work environment where people are empowered and supported in achieving their career goals. Working at Ascentage Pharma allows you to balance your priorities.
• Create a diverse and multi-disciplinary workforce at all levels
• Cultivate dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, with a shared commitment to science and to the patients we serve.

Compensation and Benefits

Ascentage Pharma offers an extremely competitive compensation package, including an annual bonus.

• We offer exceptional, Medical, Dental, and Vision plans for employees and families
• Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance
• 401K with a 6% company match
• Liberal paid time off
• Flexible schedules for staff and employee assistance program

Ascentage Pharma is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is Ascentage Pharma's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, marital status, status as a protected veteran, or any other legally protected group status.

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