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.

Job Summary
Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP) 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. Facilitate successful execution and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.

Responsibilities

Support the preparation, set‑up, execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project and quality plans, and relevant ICH/GCP Guidelines.

Review protocols to ensure designs are implementable to efficiently achieve the objectives.

Support activities to drive adherence to timelines, program objectives and monitoring plans.

Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.

Oversee the overall global oncology review process of PhIV company sponsored studies per the SOP (regional review, Global review, tracking of milestones as per contract).

Ensure the global clinical operations systems for management of company sponsored studies review and approvals are current and accurate.

Liaise and report on study activities with other relevant GOMA functions and the Global Medical Affairs Team.

Work with the Functional and Regional Teams and key stakeholders to drive alignment on key activities and expectations.

Ensure regular updates are provided to Study Lead on trial metrics, data, and quality.

Establish strong partnership with Functional and Regional Operational managers to drive operational excellence with the required functions, in regions and countries for all GOMA clinical activities.

Provide input to process standards and tools to achieve excellence in trial operations and management.

Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities.

Support the development of clinical operations related to Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable.

Qualifications

Education: Bachelor's Degree required.

Experience: 4+ years overall related, clinical trial management experience or commensurate education/experience required.

Medical Affairs experience preferred.

Project Management experience preferred.

Travel: Ability to travel up to 20% of the time.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range: USD$127,280.00 - USD$190,920.00

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