エージェント取り扱い求人

Medical Advisor (血液内科)

募集中
  • 勤務地
    東京都 大阪府
  • 職種
    臨床開発医師
  • 業種
    CRO

募集要項

業務内容 業務内容

メディカルモニタリング:日本に割り当てられたプロジェクトのメディカルアドバイザーとして以下の役割を担う

・プロトコルの明確化、組入れ基準の決定、患者さんの安全性・適格性の問題を含むプロトコル関連の問題について、プロジェクトメンバーや治験実施医療機関に対し医学的アドバイスを行う
・プロトコル、治験薬概要書、症例報告書の医学的レビューを行う
・プロジェクトチームに対し、疾患領域や適応症に関するトレーニングを提供する
・インヴェスティゲーター・ミーティングに参加する
・有害事象のレビューを行う
・ファーマコビジランス部門と協力して、重篤な有害事象のレビューを行う
・ファーマコビジランス部門と協力し、またはその代理として、累積/類似症例の分析をサポートする
・有害事象コーディングの医学的レビューを行う
・総括報告書とナラティブのレビューを行う
・キックオフミーティング、チームミーティング、クライアントミーティングに参加する
・就業時間以外にプロトコル関連する緊急問題が生じた場合は、所定のルールに従ってタイムリーに対応する
雇用形態 正社員
応募資格 候補者要件

<必須>
・日本における医師免許
・4年以上の臨床経験(研修期間含む)
・血液内科の臨床経験(研修期間含む)
・語学力

日本語:あらゆるコミュニケーションの場面におけるビジネスレベルの能力
英語:読む・書くについてビジネスレベルの能力。および、聞く・話すについて日常会話が可能であり、就業後に能力を向上する意欲があること

<尚可の条件>
・5年以上の臨床経験(研修期間含む)
・血液内科の専門医認定
・語学力

英語:あらゆるコミュニケーションの場面におけるビジネスレベルの能力。
英語力 ビジネスレベル
年収 1440万 〜 1800万円
給与詳細 1440万~1800万
勤務地 東京都 大阪府
備考

企業情報

匿名

関連する求人

エージェント取り扱い求人
Senior Manager, Japan Clinical Trial Physician

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. ​High Level Summary: The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart. Role Description Medical Monitoring Conducts medical data review of trial data, including eligibility review Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines) Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations) Fulfills GCP and compliance obligations for clinical conduct and maintains all required training The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues. Japan CTP could be expected to take a primary CTP role for local initiated trials or program Clinical Development Expertise & Strategy In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets Provides oversight and medical accountability for a group of studies Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.) Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others Health Authority Interactions & Publications Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with TA such as Clinical Lead or Clinical Scientist On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

  • 1000万〜2500万
  • 東京都
  • 医薬品メーカー(先発医薬品)

募集中