Clinical Project Manager

Vor 7 Tagen


Council of the City of Sydney, Österreich Ascentage Pharma Vollzeit

Ascentage Pharma is a global, integrated biopharmaceutical company dedicated to discovering, developing, and commercializing therapies for unmet medical needs, primarily in hematological malignancies. The company is currently conducting over 40 clinical trials in specific regions worldwide. Ascentage Pharma has been listed on the Main Board of the HKEX (stock code .HK and recently listed on NASDAQ in January under the stock code AAPG. Please note - only candidate resides with working rights in Australia should apply. Purpose of Job Leads all aspects of assigned clinical trials and demonstrate a high level of knowledge of clinical operations methodologies, organizational, project management and leadership capabilities. Leads multi-disciplinary, cross-functional study from start-up through to closeout to ensure both internal and external deliverables are on time and on budget working under the guidance and direction of the Clinical Program Leader. Works to ensure adherence to a standardized approach to clinical trial management. Ensures successful clinical trial planning, execution and delivery, within specified quality, time and cost parameters. Ensures planning, organizing, and directing the activities of personnel involved in clinical research projects to make sure that they are in line with general clinical goals and objectives. Works to ensure that the management of all aspects of clinical trial and the selection of vendors so as to guarantee the safety of patients, non-breaching of contract, procedures, and data integrity. Works as a primary contact for vendors and leads in planning and communication with diverse study teams to make sure that trials are conducted and executed effectively. Works closely with global project team. Ensures cross-functional coordination and focus to agreed strategy. Coordinates clinical activities across the project. Works with team members to drive deliverable. Primary Duties and Responsibilities Drives development and optimization of integrated program strategy. Provides, in collaboration with the Clinical Program Leader, strategic leadership to the Clinical Program Team for the clinical development of therapeutics in the pipeline. Drives, together with the Clinical Program Leader, the program strategy by planning and tracking activities, such as drug supply and formulation development, preclinical work for indication expansion and patient selection strategies, supportive clinical pharmacology and toxicology studies. Leads and contributes to organizational initiatives and external partnerships. Leads and contributes to task forces, sub-teams or broader cross-functional organizational initiatives. Manages external partnerships with other Pharmaceutical / Biotech companies or academic institutions. Achieves organizational alignment and seamless execution of the integrated development plan. Accountable for the cross-functional alignment and organization support of the integrated development plan by facilitating internal and external stakeholder management. Drives team's objective setting, prioritization, and tracking ensuring adherence to the development strategy and operational plan. Assures ongoing optimization of program timelines and resource requirements. Leads risk management and contingency planning, and monitors the implementation of risk mitigation strategies at the program level. Enables high performing teams and associates. Fosters team building, interactions, and collaboration, striving for high performing clinical program teams. Develops program team members through coaching and mentoring. Drives issue identification and resolution in alignment with concerned line functions and the program team. Ensures effective, proactive and open communications within and across the program team to achieve transparency and clarity of program goals, progress, and issues. Deputizes the Clinical Program Leader as the spokesperson for the program team. Qualification Bachelor's degree, or equivalent experience in life science and at minimum five years industry experience in drug development. Strong scientific background in Biology, Chemistry or Pharmaceutical Sciences. Several years multi- and cross-functional leadership experience in international and multidisciplinary drug development teams. Expert knowledge of drug development process incl. advanced knowledge of regulatory and business requirements. Oncology and clinical operations experience of advantage. Advanced project management skills, capable of managing multiple projects with respect to priorities and self-management. Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective international. Strong written and verbal communication skill. Apply Please submit your CV via clicking onto the "Apply" button. Please note - only shortlisted candidates will be contacted. Seniority level Mid-Senior level Employment type Full-time Job function Project Management and Information Technology #J-18808-Ljbffr



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