Clinical Operations Lead

Ascentage Pharma: (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. Ascentage Pharma is proud of its collaborative, supportive culture, unified by the 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 it succeeds in advancing its mission only as each individual experiences’ success in their role.

Leveraging our robust internal research and development capabilities, we have built a portfolio of global intellectual property rights. We have also established global collaboration relationships with leading biotechnology and pharmaceutical companies, such as AstraZeneca, Innovent, Merck, and Pfizer and research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan.

We are a leader in global innovation with a portfolio of more than U.S. and international patents and more than U.S. and international pending applications.

We have assembled a talented, global team with experience in the research and development of innovative drugs, as well as commercial manufacturing, sales and marketing. Our success is shaped by this global team of over to 700 employees across United States, Europe, Australia, and China.

The Clinical Operations Lead (COL) is responsible for supporting the Clinical Trial Manager/operational team in execution of the trial (s). The function could include direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks. Maintain effective communication with project team through oral and written correspondence, status reports to ensure alignment with study timelines. Works under general supervision.

• Assists in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
• Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
• Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Manager.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
• Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
• Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
• Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
• Participate in data review and discrepancy resolution.
• Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
• Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).
• Participate as a member of the multi-disciplinary trial(s) team.
• Develop relationships with investigational sites and institutions to enhance conduct of the trial.
• Acts as preliminary liaison for study sites to convey trial information, answer questions and act in accordance with the escalation established pathway.
• Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
• Contributes to the development of RFPs and participates in the selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors,…