Career Category
Scientific
Job Description
Job purpose
- Lead and develop product medical strategy and plan based on product strategy.
- Key member to develop product strategy and local commercial team with brand team.
- Provide Japan position on global/region disease and product related programs.
- Provide medical affair consideration on portfolio evaluation and discussion.
- Lead evidence generation and publication plan and execution.
- Implement various scientific programs in collaboration with internal stakeholders such as the Commercial or R&D
Key responsibility
- Identifies develops and maintains collaborative relationships with current and future OLs scientific experts cooperative study groups and study sites
- Partners with the brand team in the development and execution ofthe Local product(s) lifecycle management plan
- Leading and developing the LocalMedical strategy and Medical activitiesfor the product(s) in accordance tointernal and external regulations
- TA and/or product specific Medicaltraining
- Ensuringconsistency of Medicalcontent and scientific messagesacross various tools and materials
- Visits selected KOLs and study groups for strategic discussions andprotocol development
- Develops study protocols for LocalAmgen sponsored studies (AST);supportsand executes Local study protocol preparation filing reviewand approval in line with Amgen processes and policies
- Works with GSO to ensure preparation implementation andcompletion of ASTs
- Supports GSO in participation and completion of global/region studies in the country
- Reviews Local ISS proposals prior to approval and ensuresappropriate Local/region/global committee review if applicable
- Provides input into site selection for ASTs
- Oversees in-sourced/outsourced Medical programs and logistics
- Participates in/conducts Local Advisory Board Meetings InvestigatorMeetings and/or Expert Panels
- Provides Medical expertise for products
- Provides Medical expertise for Health Economy and reimbursementrequests
Basic Qualifications Selection Criteria (minimum Qualifications)
- Masters degree
- Minimum of 2 years in pharmaceutical industry or proven industrycollaboration in academia
- Oncology area knowledgeand experience
- Experience in Medical Department or Clinical Development
- Experience with clinical study management and conduct
- Knowledge of commercialization and business practices
- Fluent in Japanese and English
Preferred Qualifications Preferred Requirements
- MD PharmD or PhD is preferred
- Knowledge of pharmaceutical product development product lifecycle andcommercialization process with advanced understanding of other functions;including but not limited to Clinical Operations Commercial Regulatoryand Medical Affairs
- Network of customer contacts in therapeutic area
- Finance and budgeting experience
Competencies
- Medical and scientific expertise
- Fluency in English both oral and writtencommunications
- Strong communication and presentation skills
- Continuously expanding medical andscientific knowledge as well as marketknowledge
- Strong clinical research knowledge (studydesignstudy evaluation medical writingskills expert panel conduct symposium andworkshop management KOL management)
- Strong customer orientation; science-based
- Ability to work in a cross-functional team(e.g. Commercial Clin Development HE Regulatory Safety etc.)
- Role model for others in line with AmgenValues
- Demonstrates leadership skills
.
Required Experience:
Unclear Seniority