Amgen Clinical Research Scientist(Mgr), General Medicine in Tokyo, Japan

Purposes of the job are,

  • To facilitate/support planning and execution of Amgen sponsored clinical studies, ensuring alignment of affiliate Development TA and Development Operations

  • To generate documents with high medical/scientific quality relevant to clinical studies and reporting to health authority

  • To handle practicalities required for the execution of affiliate Medical Plan

  • To facilitate generation of affiliate-originated pre- and post launch clinic

Key activities include,

Clinical Development

  • Ensure alignment of affiliate medical strategy, study design and execution between Affiliate Development TA and Affiliate Development Operations/ external partners

  • Contribute to the design of the protocol, engaging external experts, if necessary

  • Communicate relevant local medical environment

  • Assist DFM in identifying qualified investigators/study sites

  • Support Clinical Development Operations activities.

  • Support CRA in conducting Site Engagement and Site Evaluation visits, and support remote site evaluation and central monitoring set up.

  • Develop and execute study-specific Site Relationship Management Plan for investigators to improve company and investigator relationship, including the below activities as required:

  • Enrollment support visit

  • Relationship issue management visit (Apology visit)

  • IRB support visit

  • Scientific interaction visit

  • Act as an interface between study team (RCTM) and AABP Project Team

  • Coordinate providing scientific/medical content to address IRB/EC/national authority issues.

  • Assist Affiliate Development Operations in protocol interpretation

  • Scientifically review and edit documents relevant to global development and local medical /clinical activities

  • Review translated version of documents relevant to global development and local medical /clinical activities

  • Author/review/edit assigned part of CTD collaborating with Medical Director/Sr. Medical Advisor and Medical Writer

  • Support Affiliate Medical Directors/Medical Advisors in developing responses to queries from regulatory agencies

  • Organize advisory board meetings; data monitoring committees and steering/executive committees coordinating contracts

Medical Plan

  • Write protocols for, execute and publish the results of, pre-and post-launch local studies, collaborating with relevant internal/external stakeholders and external vendors.

  • Manage vendors controlling budget and contracts

  • Handle Consultancy Agreements and other Service Agreements with external experts for contracts owned by global/affiliate Development TA

  • Handle contracts with potential investigators for Investigator Sponsored Studies

Basic Qualifications

  • BA/BS/BSc

  • Three (3) or more years of clinical research experience and/or academic research experience including experience working on clinical trials

  • Plus 2 year experience in study site-monitoring

Skills, Knowledge and Experience

  • Proficiency understanding the clinical strategy for products in the relevant therapeutic area

  • Extensive knowledge of Good Clinical Practices (GCP), HA regulations and guidelines, and international regulatory requirements/guidelines

  • Experience planning and conducting epidemiologic studies/surveys (preferred)

  • Experience collaborating with external scientists

  • Experience conducting clinical trials in the relevant therapeutic area

  • Vendor management experience (preferred)

  • Project management/project planning experience (preferred)

  • Ability to provide scientific expertise to a clinical development program

  • Proficiency in anticipating and resolving problems

  • Experience writing and presenting clearly on scientific and clinical issues

  • Experience leading teams in a matrix environment

  • Excellent interpersonal and organizational skills

  • Professional collaboration and leadership skills

  • 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

  • Language proficiency in both Japanese and English (business discussions, reading, and writing)