Executive Director, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operation

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Lead the Global Clinical Operations Team by providing strategic and tactical guidance and support for clinical staff with high degree of quality in the execution of all Global Medical Affairs medical activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Deliver Evidence Generation projects in preparation for launch activities in Oncology Business unit countries as well in other Regions.

Responsible for all primary data generation in GMA studies (i.e. Company Initiated Interventional Studies (CIS), Non-interventional Studies (NIS), Expanded Access Programs (EAP), Investigator Initiated studies (IIS) and External Collaborative Study Research projects (ECSR)). Ensure successful execution, timelines and clinical milestones. Accountable for overall Clinical Operation performance against key metrics Accountable for all budget related management

• Clinical Operations Study/ Program Management Responsible for primary data evidence generation delivery of GMA programs:
  Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions. Ensure preparation and execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, quality plans, and relevant ICH/GCP Guidelines Provide strategic input into the development of the protocols to ensure designs are implementable to efficiently achieve the objectives.
  
  Provide strategic input in the development of CRFs, ICFs, Monitoring Plans, final reports and publications as applicable. Develop, implement and ensure adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems. Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, safety updates/ notifications etc Ensure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership Have a robust management plan in place before starting a study/ program to ensure optimal control and monitoring, to minimize risks and ensure timely response to treating physicians Investigator Initiated Studies (IIS) and External Collaborative Research Studies (ECSR) Provide oversight of the overall IIS process related to third-party Investigator Initiated Studies IIS and External Collaborative Research Studies (ECSR) as per the Standard Operating Procedure (SOP)(regional review, Global review, tracking of milestones as per contract) Ensure the IIS process is revisited regularly to adhere to the (SOP) and identify and remediate/correct any gaps on a timely manner to ensure robust preparation and review by the…