About the Role
Clinical Development Scientist (CDS) contributes to the advancement of clinical development projects and the acquisition of approvals in Japan. This role involves close collaboration with the Japan Development Lead, overseeing clinical trial planning, execution, and submission processes. The CDS will also work with global teams to enhance clinical trial efficiency and maximize the value of the Japanese development organization. This position offers an opportunity to leverage clinical development expertise, further develop comprehensive clinical development capabilities, and build a foundation for future diverse roles within Development Japan. The current opening is for a CDS focused on internal medicine projects, particularly in cardiovascular and metabolic diseases.
Responsibilities
- Driving clinical development programs (Phase 1 to approval) within respective therapeutic areas.
- Creating and reviewing clinical trial-related documents (e.g., protocols, informed consent forms, CRFs).
- Supporting the creation of documents for regulatory submissions and interactions with authorities (e.g., CSRs, CTDs, PMDA consultation materials, responses to inquiries).
- Facilitating the smooth execution of clinical trials under the guidance of the Japan Development Lead.
- Introducing and utilizing new methodologies and tools, such as Patient-Reported Outcomes (PROs).
- Conducting and providing information necessary for clinical development planning and trial execution.
- Sharing information and improving the accuracy of clinical trials through collaboration with global teams and relevant departments.
- Contributing to the improvement of clinical development processes and SOP development.
- Promoting quantitative decision-making through collaboration among clinical, statistical, and clinical pharmacology personnel.
Requirements
- Academic background in a science field (graduate school or a 6-year program such as pharmacy).
- Over 5 years of experience in the pharmaceutical industry with an interest in and understanding of clinical development.
- Proficiency in document creation and communication in both Japanese and English.
- Negotiation skills, problem-solving abilities, and interpersonal communication skills.
Skills
- Clinical development
- Document creation
- Communication
- Negotiation
- Problem-solving
- Interpersonal communication
Location
- Japan
Work Type
- Hybrid
Experience Level
- 5+ years in pharmaceutical industry
- Clinical development experience (preferred)
Education Level
- Graduate school or 6-year science program (e.g., pharmacy)
About the Company
- Pfizer's culture emphasizes individual ownership and a belief in improving future healthcare and transforming millions of lives.
- Pfizer is seeking new talent to join its global community and discover innovative therapies that contribute to a healthier world.
Equal Opportunity
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
- Candidates are advised to review Pfizer's candidate AI-use guidelines for acceptable and prohibited uses of AI during the recruitment process.
