Clinical Biomarker Project Manager

About Ascentage Pharma:

Ascentage is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and senesce diseases.

Ascentage Pharma is an integrated global biopharmaceutical company engaged in discovering, developing and commercializing both first- and best-in-class cancer therapies. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK and on January 2025 we were listed on Nasdaq (AAPG).

We are empowered by our technical expertise in structure-based drug design and our innovative drug discovery engine, which allows us to address unmet medical need by targeting key apoptotic pathways and validated tyrosine kinases. We are the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators that restore programmed cell death. These core competencies have allowed us to develop small molecule and degrader therapies targeted at Bcl-2, Bcl-2/Bcl-xL, IAP and MDM2, in addition to building next-generation cell signaling inhibitors (i.e., BCR-ABL1, ALK, FAK inhibitors) and epigenome-modifying agents (i.e., EED inhibitor).

Olverembatinib (HQP1351) is a novel, next-generation TKI. Olverembatinib is the first and only third generation BCR-ABL1 inhibitor approved in China for CML patients. Olverembatinib was included as an Emerging Treatment Option in the 2024 National Comprehensive Cancer Network, or NCCN, guidelines for the management of CML and received recommendation from the Chinese Society of Clinical Oncology, or CSCO, guideline for the treatment of Ph+ ALL.

Lisaftoclax (APG-2575) is a novel Bcl-2 inhibitor. To date, the FDA has granted five ODDs to lisaftoclax, including for the treatment of CLL, AML and MM. As of December 31, 2023, more than 800 patients have been treated with lisaftoclax as a monotherapy or combination therapy in clinical trials conducted in United States, Australia, China, and Europe, among which approximately 400 patients have CLL/SLL.

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 close to 600 employees across United States, Europe, Australia, and China.

Responsible for developing and implementing biomarker strategies to support clinical development within a diverse global portfolio. Key accountabilities of this position include 1) Develop and implement biomarker strategies to support investigative, exploratory and regulated clinical studies, 2) Manage and maintain strong collaborations with external vendors.

Major Responsibilities

• Broad scope of team influence and depth of knowledge with responsibility for the development of biomarker strategies for clinical trials in Oncology. Biomarker strategies will include hypothesis-driven novel biomarker identification and established biomarker evaluation in clinical trial samples.
• Apply theoretical and technical biomarker expertise to ask the correct questions, identify gaps, prioritize key issues and bring together the appropriate internal or external biomarker labs to address needs across a diverse and global portfolio. Challenges status quo in order to foster innovation.
• Partner across functional groups within R&D to ensure effective clinical translation of biomarker strategies. Develops and manages plans to achieve biomarker objectives and resource requirements within projects. Identify and bring together the needed biomarker lab expertise to impact projects.
• Independently analyze and interpret biomarker data to design follow-up biomarker studies if needed, and effectively communicate biomarker data to project teams and larger audiences as part of a collaborative multidisciplinary group.
• Track and manage the process of clinical biomarker sample collection, shipment, analysis and data report.
• Establish and oversee effective collaboration with external vendors for high quality deliverables.

Required Qualifications

• PhD with at least 3 years in clinical biomarker experience including developing strategies in academic (translational discipline) or industry settings required.
• Strategic expert in biomarker discipline with recognized subject matter expertise across multiple biomarker capabilities/platforms for blood, tissue and genomic analysis.
• Strong project management skills to ensure on time deliverables.
• The successful candidate will have demonstrated ability to work across functional lines and geographical locations, to effectively communicate with lab functions both within and outside biomarker team
• Excellent oral and written communication skills are a necessity, as well as the ability to multitask across a diverse portfolio of projects.

To apply please send your CV to hr@ascentage.com

Please no agencies.