R&D Oncology Clinical Development Associate Director
No salary listed
Expert
PhD
Chiyoda City, Tokyo, Japan
HybridHybrid work arrangement; domestic and international travel is possible.
Biology & BiotechClinical Research Operations
About the job
Requirements
- A physician's license is required.
- At least five years of domestic clinical experience, including experience in oncology, is required.
- Experience in domestic or international company-sponsored clinical trials, academic clinical research, or physician- or investigator-initiated trials or research is preferred, with approximately three or more years as a guideline.
- Native-level Japanese proficiency is required.
- Business-level English proficiency is required for smooth scientific, medical, and general business discussions and daily work with global colleagues, particularly spoken conversation.
- Practical experience and leadership in oncology clinical research and development or medical affairs is required, with approximately two to five years as a guideline.
- Sound understanding of applicable laws, regulations, guidelines, and guidance, and the ability to make balanced compliance decisions based on that knowledge.
- Ability to think strategically and logically and demonstrate practical skills in both scientific and operational work.
- Experience working in cross-functional and cross-border organizational and work environments.
- Established network among domestic physicians, researchers, and healthcare professionals in oncology, with the ability to exert influence externally.
- Established interpersonal communication and presentation skills for close collaboration with internal domestic and international departments and external medical specialists.
- Availability for domestic and international travel, including to conferences and clinical trial or research sites.
- Overseas study experience is preferred.
- Ability to act independently and work efficiently and effectively to deliver results in a continually changing, challenging environment.
- A doctoral degree in medicine, pharmacy, nursing, or a natural sciences field is preferred.
- Skills include clinical research, clinical trial planning, clinical trials monitoring, electronic data capture, ethical standards, key opinion leader management, medical staff relations, medical teamwork, professional networking, pharmacology, pharmacotherapeutics, pharmacotherapy, physician relations, protocol development, scientific consulting, and writing and reviewing.
Responsibilities
- Provide medical expert advice on development projects as a member of development teams and medically review documents, including clinical study protocols and regulatory submission materials.
- Advise on and manage immune-related adverse events and other adverse events and serious adverse events, including communicating with internal and external stakeholders.
- Provide medical education to internal departments, including lectures for internal teams and introductions to relevant papers.
- Lead early- and late-stage oncology development projects, including developing strategic development plans, designing protocols, and managing preparation of clinical study reports.
- Coordinate internally and externally with relevant departments, contract research organizations, and key opinion leaders to conduct clinical trials, and manage trial progress.
- Collaborate with overseas global teams and counterparts and respond to regulatory authorities.
- Plan and operate advisory board meetings related to domestic development, and support global research and development advisory board activities, including recommending and supporting researchers.
- Prepare regulatory submission materials and responses to regulatory inquiries, review responses, and attend and participate in discussions at regulatory consultations as the clinical representative.
- Create publication plans and manage publication processes.
- Write review articles and other papers about products.
- Collect scientific and medical information at domestic and international conferences.
- Support and manage scientific and medical engagement between physicians and healthcare professionals and global headquarters.
About the company
Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.
Company Size
10,001+
Company Stage
IPO
Headquarters
Rahway, New Jersey
Founded
1891
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Simplify's Take
What believers are saying
- U.S. employees build retirement benefits: Merck pairs a defined benefit pension with a matching 401(k).
- Scientists work within a large research network: Merck reports approximately 24,700 employees in R&D.
- Animal health adds growth: August 2026 results report Q2 sales of $1.8 billion, up 8% year over year.
What critics are saying
- Job security faces cuts: Merck's active restructuring program eliminates roles and shrinks its global real estate footprint.
- Keytruda protection narrows: its main U.S. patent expires in 2028, with additional patents expiring in 2029.
- Revenue is concentrated: August 2026 results show Keytruda products generated $8.4 billion of Merck's $16.6 billion Q2 sales.
What makes Merck unique
- Merck extends into farm technology: SenseHub continuously monitors livestock for behavioral and physiological changes.
- Merck publishes open medical knowledge: its Manuals give clinicians and patients free online references.
- Merck's donation commitment is open-ended: Mectizan supplies for river blindness continue for as long as needed.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Retirement Plan
- 401(k) Company Match
- Paid Vacation
- Paid Sick Leave
- Hybrid Work Options