Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this R&D Oncology Japan Clinical Director (Non-MD) role.
Rezi rewrites your resume against MSD's job description. Free.
Tailor your resume to this R&D Oncology Japan Clinical Director (Non-MD) role.
Rezi rewrites your resume against MSD's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the R&D Oncology Japan Clinical Director (Non-MD) posting at MSD — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the R&D Oncology Japan Clinical Director (Non-MD) posting at MSD — free, in seconds.
About the Role
Seeking a Japan Clinical Director to lead early and late-stage development projects in the Oncology field. This role involves internal and external negotiations, progress management, collaboration with global teams, regulatory affairs, and publication activities.
Responsibilities
- Lead early and late-stage development projects in Oncology.
- Manage strategic development planning, protocol design, and final report creation.
- Negotiate and manage progress for clinical trial execution with internal departments, CROs, and KOLs.
- Collaborate with overseas global team counterparts.
- Handle regulatory affairs in coordination with the pharmaceutical affairs department.
- Plan and manage advisory board meetings for domestic development.
- Engage in advisory board activities related to global R&D, including researcher recommendations and support.
- Prepare submission documents for regulatory authorities.
- Respond to inquiries and review documentation for regulatory submissions.
- Attend and participate in discussions with regulatory authorities as a clinical representative.
- Create publication plans and manage publication processes.
- Author articles such as reviews on products.
- Gather scientific and medical information at domestic and international conferences.
- Support and manage scientific and medical engagement activities between physicians/healthcare professionals and the global headquarters.
Requirements
- Master's degree in a science field (required).
- Pharmacist qualification (preferred).
- PhD in Medicine, Pharmacy, Nursing, or Natural Sciences (preferred).
- Native-level Japanese language proficiency (required).
- Business-level English proficiency for smooth discussions and daily operations with global stakeholders (required).
- Clinical development practical experience and approval application experience as an Oncology project leader in a pharmaceutical company (required).
- Disease knowledge in the Oncology field (required).
- High ethical standards and a balanced compliance judgment based on a solid understanding of relevant laws, regulations, guidelines, and guidance.
- Strategic and logical thinking abilities, with practical skills in both science and operations.
- Experience working in cross-functional and cross-border organizations and work environments.
- Established network with domestic physicians, researchers, and healthcare professionals in the cancer field, with the ability to exert significant external influence.
- Established interpersonal and presentation skills for close collaboration with internal (domestic/international) related departments and external experts.
- Willingness to travel domestically and internationally (conferences, clinical trial/research facilities, etc.).
- Ability to act proactively and achieve results efficiently and effectively in a constantly changing, challenging environment.
- This is a manager-level position.
Skills
- Biomarker Assay Development
- Clinical Research
- Clinical Site Management
- Clinical Study Design
- Clinical Trials Operations
- Detail-Oriented
- Ethical Compliance
- Ethical Standards
- Good Clinical Practice (GCP)
- Medical Writing
- Multiple Therapeutic Areas
- Patient Recruitment
- Scientific Writing
- Strategic Thinking
- Veterinary Research
Location
- Japan
Work Type
- Hybrid
- Full-time
Experience Level
- Manager
Education Level
- Master's Degree
- PhD
- Pharmacist
About the Company
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.