JOB PROFILE: Clinical Operations Lead (COL)
Ascentage Pharma – Who we are:
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, Takeda, 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.
Job Description Summary:
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 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.
Primary Duties and Responsibilities
- Assist in the review and/or development of clinical trial documents, plans, and manuals.
- Contribute to development Master ICF templates and review country- and site-level changes in accordance with current approved protocol.
- Gather and collate feasibility data and document collection for potential investigative sites; participate in the site budget review and negotiation process under the supervision of the Clinical Trial Manager.
- Plan and organize internal and external meetings with team support (e.g., weekly cross-functional team calls, investigator/coordinator meetings, etc.).
- Participate in data review and discrepancy resolution.
- In coordination with Clinical Trial Manager, monitor study-specific timelines, milestones, and key deliverables, inclusive of oversight support for selected activities performed by external vendors.
- Participate as a member of the broader multi-disciplinary trial team.
- Develop relationships with investigation sites and institutions to enhance conduct of the trial.
- Perform special projects, as assigned, to improve the efficiency, effectiveness, and quality of the Clinical Operations function within Ascentage.
- Proactively identify project issues and risks and escalate and/or resolve as appropriate.
- Track, monitor, and routinely report trial and site progress on behalf of the study team.
- Monitor ongoing compilation and perform quality control reviews, as assigned, of the Trial Master File (TMF) to ensure inspection readiness.
- May provide leadership and guidance to other clinical operations staff members (Clinical Trial Associates).
Knowledge/Skills/Abilities Required
- The minimum level of education and years of relevant work experience:
- Bachelor’s degree in life sciences or related field, or equivalent combination of education and/or training.
- At least two (2) years of clinical trial or clinical operations experience in a biopharmaceutical, CRO, or equivalent clinical research setting, including experience supporting or coordinating clinical study management activities.
- Strong project management skills with the ability to deliver results on schedule in a fast-paced, entrepreneurial environment.
- Recent experience working on oncology trials is preferred.
- Basic knowledge of clinical research operations, and thorough understanding of GCP/ICH guidelines.
- Strong attention to detail and accuracy, timeliness, self-motivation, developed organizational skills, and ability to work both as part of a team and independently.
- Substantial problem solving and analytical skills and identifies issues and problems and formulates potential solutions proactively.
- Demonstrated communication skills, including presentation and writing skills. Demonstrated positive interpersonal skills; ability to actively maintain good professional relationships.
- Ability to effectively interface with medical personnel at clinical sites.
- Ability to write and edit technical documents, such as informed consents and other trial-related documents.
- Demonstrated ability to handle multiple competing priorities.
- Demonstrated ability to work productively as part of a matrixed team in a growing and changing environment.
- Knowledge of electronic data capture, as well as electronic TMF set-up, maintenance, and management of essential documents.
- Computer skills include high proficiency in the use of a laptop computer and Microsoft Office Suite: Outlook, Word, Excel, and PowerPoint.
Location
- Ascentage Pharma is based in Rockville, MD, however, this position can be remote anywhere in the US.
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
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. Short-Term and Long-Term disability, parental leave, and a matching 401(k) program (immediate vesting).
- Generous PTO and holidays, as well as floating holidays to encourage balance and recharge.
- Training, International conference attendance and inter-departmental exposure for career growth allowing for leadership opportunities within the company.
- 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, STD, LTD, 401(k), and more), annual target bonuses and eligibility to receive equity. Actual pay is based on a myriad of factors such as location, experience, skills, education, and internal equity.
About Ascentage Pharma
Ascentage Pharma (NASDAQ: AAPG and HKEX: 6855) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. In January of 2025 Ascentage went public on NASDAQ. In July 2025 we announced that our proprietary novel Bcl-2 selective inhibitor Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.