Amgen Sr Medical Advisor Oncology in Tokyo, Japan

Responsible for:

  • Provide in depth local medical/clinical and scientific (as applicable) insights to local and global product teams

  • Product(s) lifecycle management

  • Leading and developing the Local Medical strategy and Medical activities for the product candidate(s) in accordance to internal and external regulations and in close collaboration with all other functions as needed

  • TA and/or product specific Medical training

  • Management of internal and external relationships within area of responsibility

  • Ensuring consistency of Medical content and scientific messages across various tools and materials

  • Providing in depth local medical/clinical insights

Key Activities:

  • Participates in the development of Japan strategies and tactics under supervision of the AABP Medical Director and in close collaboration with the AABP product teams (PT) and the PSTs and all relevant functions at AABP

  • Supports local study concept development and protocol preparation (as well as global studies with Japan participation) in close collaboration with Amgen GDT and DCD, based on agreed upon development strategy, all in line with Amgen processes and policies

  • Visits selected KOL's and study groups for strategic discussions and protocol development

  • Participates in/plans and conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels

  • Contributes to the formulation of regulatory submission strategy

  • Provides Medical expertise for pipeline products

  • Provides Medical expertise for Health Economy and reimbursement requests

  • Member of the AABP PT and Joint Product Team

  • Collaborates closely with AABP PT, Development Operations (DO) and all other functions as needed to ensure preparation, implementation and completion of AST's (Amgen sponsored studies)

  • Provides input into site selection for AST's

  • Review IB, SCD/protocol, study report

  • Contribute to preparation of CTD as appropriate

  • Reviews Japan Investigator-Sponsored Study (ISS) proposals to ensure scientific validity, prior to appropriate governance-based review

  • Collaborates with the AABP PTs, JPTs and PSTs as well as AABP Marketing and Scientific Affairs teams in the development and execution of the Japan product(s) lifecycle management plan

  • Develops and executes better recruitment strategies in conjunction with Local Development Operations (DO) team

  • For early development projects, collect relevant information on local medical/clinical environment, provide it to PT with strategic options and recommendations.

Basic Qualifications

Qualifications

  • Medical education (MD) or deep scientific expertise in relevant therapeutic area

Skill, Experience and Knowledge

  • Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia

  • Experience in Medical Affairs and Clinical Development

  • Experience with clinical study management and conduct

  • Knowledge of commercialization and business practices

  • Deep understanding of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and Policy

  • Existing therapeutic area knowledge and demonstrated ability to rapidly develop deep understanding of new therapeutic areas

  • Strong customer orientation; science based and marketing minded

  • Existing network of OL contacts in therapeutic area

  • Finance and budgeting experience

  • Operational excellence: self management skills, planning, prioritization, objective setting, meeting management, plan execution

  • Interpersonal skills: ability to engage with key stakeholders at a professional and clinical level