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
Job Description
Responsibilities
- Lead the Medical Monitoring Center of Excellence strategy, operating model, and governance across Oncology Clinical Development, including standard roles and responsibilities, escalation pathways, monitoring expectations, quality standards, decision documentation, and cross-functional interfaces that enable consistent execution across programs and studies.
- Develop, maintain, and improve medical monitoring standards, templates, job aids, playbooks, training materials, and quality measures to support study start-up, ongoing trial conduct, safety review, protocol deviation management, data review, query resolution, issue escalation, and inspection readiness.
- Provide expert consultation and oversight for complex medical monitoring issues across programs, including patient safety concerns, eligibility and treatment decisions, emerging safety signals, protocol interpretation, risk mitigation plans, and alignment of medical monitoring practices with clinical development strategy, regulatory expectations, and cross-functional governance.
- Partner with clinical development leaders, medical monitors, study physicians, clinical operations, CSPV, quality, regulatory, data management, biostatistics, vendors, CROs, and external experts to drive consistent medical monitoring execution, resolve cross-functional issues, and strengthen communication with study teams and clinical sites when medical input is required.
- Establish metrics, lessons-learned mechanisms, and continuous improvement initiatives to assess medical monitoring effectiveness, identify capability gaps, promote best practices, and support functional excellence priorities across the oncology portfolio.
Qualifications
Education Qualifications
- MD required.
- Board certification in Oncology, Hematology/Oncology, or relevant specialty preferred
Experience Qualifications
- At least 10 years of pharmaceutical, biotechnology, or clinical research experience, with substantial experience in clinical development and medical monitoring.
- Demonstrated experience leading or overseeing medical monitoring activities across global oncology clinical trials.
- Experience developing standards, processes, training, governance, or capability-building initiatives within Clinical Development or a related function.
- Strong working knowledge of GCP, clinical trial conduct, safety oversight, regulatory expectations, inspection readiness, and cross-functional study governance
Travel Requirements
Ability to travel up to 20% of the time. Global travel might be required
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$251,250.00 - USD$418,750.00