Reporting to the Director / V.P. Clinical Operations in Hangzhou China, this position is responsible for the performance of the company clinical data management (CDM) function. The Director/Sr. Director recommends and executes strategies in collaboration with Senior Management, Apollomics US to ensure successful outcomes for projects/studies. This position has advanced knowledge of Electronic Data Capture and industry standards, and advanced skills partnering with contract research organizations (CROs) and other third-party vendors. This position requires advanced knowledge of clinical trial conduct, relevant regulatory requirements, excellent verbal/written skills, analytical, organizational, and interpersonal skills and collaborates effectively with stakeholders at different levels, disciplines, and cultures. Experience with Phase 1 to Phase 4 studies within the biotechnology and/or pharmaceutical industry across multiple therapeutic areas, with emphasis in oncology development, is highly desirable. This is a full-time position.
- Responsible for the performance of the company CDM function and the development of CDM team members, as needed.
- Acts as data management point of contact for senior management and high-level internal and external stakeholders.
- Collaborates with other functions to ensure effective cross-functional communication throughout drug development process to resolve issues and support studies.
- Proactively identifies and manages risks for CDM and supports functional risk identification/management efforts.
- Collaborates with existing China partners and future development partners in standardizing data structure to ensure seamless integration of data for regulatory reporting.
- Directs departmental resource planning and timeline setting.
- Monitors trends in departmental performance via quality, time, and cost indicators, and makes recommendations for improvements.
- Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly
- Collaborates cross-functionally during interactions with regulatory authorities and other key external stakeholders.
- Ensures data management has the appropriate skills, processes, and tools to achieve company objectives.
- Influences data management processes and tools based on emerging trends, technology, and best practices.
- Author/Approve standard operating procedures, work instructions, templates/forms.
- Advises on database implementations and EDC vendor procurement.
- Advises on electronic case report forms and data management documentation.
- SDTM, CDISC/CDASH experience with datasets.
- MS/BS in life sciences or related field.
- Fluent in Chinese, native speaker preferred. Good command of English.
- 12+ years data management and/or related work experience in a biotechnology or pharmaceutical company, or similar environment (e.g., CRO).
- 8+ years managing people.
- Previous and recent NDA and BLA experience, as well as thorough understanding of clinical study objectives and the drug development process, including GCP and medical terminology.
- Excellent leadership and mentoring skills in managing a team of data management professionals: prior track record with staffing the function to scale with the organization’s needs.
- Clear and effective communicator to both technical and non-technical audiences.
- Enjoys and prefers a small growing company environment, where s/he must equally be comfortable with leading, stewarding, doing, and building.
- Ability to be flexible and adapt quickly to the changing needs of the organization.
- Ability to organize multiple work assignments and establish priorities.
- Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.
About Apollomics, Inc.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.