【東京都　大手外資系製薬メーカー】　

一般内科、循環器内科、内分泌内科、一般外科、製薬会社

その他
"Medical Monitoring
Contributes to and is a key member of a high performing Study Delivery Team (SDT) and is a member of the Japan Clinical Development Team (J CDT)
Conducts medical data review of trial data, including eligibility review
Holds responsibility for site interactions in partnership with the Japan Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
Collaborates with Japan CS 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
Japan CTP is expected to assist global CTP, provide local medical related input, resolve local medical related issues.

Clinical Development Expertise & Strategy
In collaboration with the Japan Clinical Development Lead, designs and develops 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 in a matrix team environment working with Japan CS
Partners with Japan CS to support executional delivery of studies (e.g., site activation, enrollment status, 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. Keeps up-to-date 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 CS to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications
Contributes to 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 Clinical Scientists"

5.0日

(月～金) 09時00分 ～ 17時15分
9：00-17：15（休憩60分、実働時間7時間15分） 　フレックスタイム制あり

なし

日曜日、祝日、土曜日

季節休暇、年末年始、その他休暇、初年度有給休暇

なし

1000万円 ～ 応相談

健康保険、雇用保険、労災保険、厚生年金

あり

あり（3か月間）同条件

【給与】
※年収1000万円～（目安の金額になります）
※経験・スキルによります。"
【勤務地】
※東京都千代田区
"【必須条件】
・臨床経験3年以上（当該領域の経験）
・ビジネスレベルの英語力
・治験参加の経験"
"【歓迎スキル】
・PhD保有
・海外留学経験"