求人・転職情報

■お任せしたいミッション
弊社の医療データ事業部は、既存のサービス事業者よりも深い診療情報データ利活用により患者さん・医療機関・製薬会社へと価値を提供し、社会に貢献することを目的としています。
今回募集するのは、製薬企業に対するRWD解析サービスのMedicalDoctor(MD)ポジションです。
医療データ事業のチームはBizDev/PM、DA(DataAnalytics)の２体制を取っており、MDはそれぞれに対して専門知識・経験を得意領域を活かして携わります。各案件にそれぞれの担当がアサインされますが、MDには具体的には以下のような業務をお任せします。

・製薬企業の考えるニーズに応じたリサーチクエスチョンの考案、研究計画・解析計画の作成
・医学的視点でのデータ抽出業務の支援（データ取得範囲の規定、カルテ等の平文からのデータ取得方法の検討、取得済データのレビュー、解析手法に関する検討や実施など）
・解析結果の考察
・当社リサーチチームと協力しての論文化
・クライアントへの提案業務のサポート
など

リサーチチームHP：https://txpmedical.jp/service/research

■チームメンバー
メンバーの一部をご紹介します。
・臨床医を15年以上経験した後、製薬企業のメディカル部門でRWD活用を進めたBizDev/PM
・臨床経験10年、原著論文100本以上の執筆経験のあるMPHホルダーの医師
・臨床経験豊富な救急専門医・内科専門医・がん診療専門医（兼業、専業含む）が複数名
・複数のCROで臨床開発や製造販売後、RWD、DM、PVの複数プロジェクトのリード経験者
・アカデミアやCROでの臨床研究の豊富なプロジェクトマネジメント経験者
・コンサルティングファームを経て医療データ解析のベンチャー企業経験者

臨床チームを率いる。臨床フェーズI～III試験およびグローバル製品登録に関わる社内の専門家によるクロスファンクショナルチームである。
複雑なプロジェクト（例：他社との共同開発）を担当し、チームメンバーとともにプロジェクト関連の目標を設定する。
臨床チームメンバーの要請を行い、機能部門の責任者とリソースの可用性を確認する。
臨床開発（CLD）を代表してJ-プロジェクトチームのメンバーを務め、またCLDを代表してローンチチームのメンバーも務める。
複数の部門からの意見を取りまとめ、コンセンサスを構築する。
関連する主要部門と協議のうえ、臨床開発計画（CDP）を作成する。
承認されたCDPに基づき、臨床試験のスケジュールを計画・管理する責任を負う。
国内試験のコンセプトを提供し、グローバル戦略との整合性を確保する。
必要に応じて積極的に是正措置を開始する。
日本での承認まで、化合物のリスク・ベネフィット評価を継続的に担当する。
入手した臨床データや関連する医療・科学情報を分析し、適切な対応や意思決定を行う。
CLD責任者およびグローバル臨床リーダーと協議のうえ、医療プロジェクトおよび試験戦略、試験結果、臨床プロジェクト結果を社内外（例：規制当局）に評価・報告する責任を負う。
戦略的アプローチを定義し、主要な規制文書（J-CTDモジュール2）の医療関連部分の作成管理を担当する。
グローバル臨床リーダー、臨床科学、臨床統計、規制、PHVと協議し、翻訳済み治験責任医師向け資料（IB）を作成・管理する。
マーケティング（販売中製品および開発プロジェクト）に医療専門知識を提供し、メディカルアフェアーズ（MA）とともに出版戦略を策定する。
出版物の内容が臨床データおよび出版戦略と整合していることを保証する。
オピニオンリーダーの育成や出版戦略に関わり、実施の詳細を支援する。
適切な外部科学諮問委員会を設立・維持し、アドボカシー開発を支援する。
開発プロジェクトのイン・アウトライセンス機会の医療評価を行う。
臨床開発業務を独立して遂行しつつ、例外的または複雑な課題については上級臨床リーダーやマネージャーに助言を求める

臨床試験医師は、日本の臨床リードおよびグローバルの臨床担当者と密接に連携しながら、臨床開発戦略の策定、試験の設計・実施・解析に貢献し推進します。

Project Physician (PP) is a medical expert who is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for AZ assets in Japan.His/Her accountability/responsibility is mainly at project-level, however, he/she is also involved in study-level activities as needed.

Other major responsibilities/accountabilities include but are not limited to:

Generate Japan clinical development strategy in collaboration with Clinical Scientist (CS) by providing expert knowledge as a physician-scientist, influencing the study design such that it reflects clinical practice, evolving landscape of medicine, regulatory and reimbursement requirements and that it meets the strategic program objectives.
Draft and/or review study design, regulatory documents to ensure alignment with agreed clinical development strategy.
Be responsible/accountable for KEE engagement from R&D perspectives including but not limited to group advisory board mtg and 1:1 consultation as local internal medical expert to lead scientific discussion for clinical development strategy in collaboration with CS and global teams.
Act as a study physician of Japan standalone studies as well as support global study physicians of global leading studies

大阪エリアを管理する専属産業医として従事いただきます。主な業務は以下となります。

・他拠点の産業医との連携、産業保健活動全般の方針策定、産業保健スタッフの労務管理
・健康診断の実施、その結果に基づく労働者の健康保持するための措置
・1か月当たり80時間超の長時間労働者に対する面接、指導等、事後措置
・ストレスチェックにおける高ストレス者への面接指導、事後措置
・休復職支援、面接、指導等　
・作業環境の維持管理（月１回の職場巡視、安全衛生委員会への参加）、衛生教育等
・労働者の健康障害の原因の調査、再発防止のための措置
・労働者の健康維持、予防に関する教育等　など

■ Overall Purpose of The Job (Brief description of the primary purpose of this position)
• This position serves as the TRICARE Near Patient Physician for Japan and will be assigned a specific
TOP Prime and Remote population within Japan which they are responsible for. This position provides
clear medical leadership for the Near Patient efforts within Japan to include both Prime and Prime
Remote beneficiaries under the direction of the Near Patient Physician Lead and Regional Medical
Director Near Patient.
The Program provides end-to-end care experience facilitation for TRICARE beneficiaries as they
journey through purchased care sector provider care in selected regions outside the United States. This
physician serves as the liaison between the local Near Patient staff (nurses and administrator), the MTF
(Military Treatment Facility) leadership, and the PCSPs (Purchased Care Sector Providers). This
includes:
• Training other Near Patient Physicians about International SOS, the US Military health care system,
and the TRICARE Overseas Program (TOP).
• Promoting and facilitating the education of PCSPs regarding International SOS, the US Military health
care system, and the TOP.
• Promoting and facilitating the education of MTF leadership regarding International SOS, TOP, and the
Near Patient goals.
• Qualified and experienced medical practitioner who understands nuances of host nation medical care
and understands US beneficiary expectations of care
• Establish and maintain effective and strong relationships with PCSPs.
• Establish and maintain effective and strong relationships with medical leadership at MTFs
• Build effective relationships with the Near Patient Nurse Lead, other Near Patient Team Nurses, and
physicians, Near Patient Program Operational Staff, Near Patient Regional Medical Director PAC, and
TOP Leadership

■Key Responsibilities (Critical responsibilities and skills of this position, listed in order of importance)
Near Patient (TRICARE)
• Management and Administration (TRICARE)
o Through direct supervision, provide support to the Near Patient medical teams in the area of
responsibility.
o Facilitate effective positive teamwork and clear channels of communication both internally and
externally.
o Establish regular communication mechanisms to ensure the effective transmission of
information to TOP medical staff on organizational and business objectives.
o Interface with the Near Patient Physician Lead and the Near Patient Regional Medical
Director to assure effective alignment.
o Provides regular reports on the status of the program to include any interactions with the
MTF, network and International SOS staff as well as any feedback to include compliments,
complaints, and suggestions from these stakeholders.
• Service Delivery, Management and Administration
o Executes strategic TRICARE initiatives in the region, as they relate to the Near Patient
Program.
o Demonstrate an understanding of the differences in the scope of services we provide the
client.
o Knowledge and adherence to International SOS internal policies and procedures, as well as
policies and procedures outlined by our clients.
o Ensure that patient information is stored appropriately in related systems and follows the
internal procedures on privacy. Patient information is not shared with other departments or
externally.
o Communication with clients and colleagues through emails or confirmations is professional
and meets business standards.
o Achieve relevant objectives / KPI’s as outlined by Near Patient Regional Medical Director.
o Ensure the beneficiary experience at PCSPs is measured and that patient needs are
supported
o Delivers Inpatient Medical Management within the AOR
o Takes escalations as required from Near Patient nurses

US Government Liaison
• Demonstrate an understanding of the TOP key contractual requirements and work closely with the Head
of Medical Services to ensure that relationships with the US Department of Defense, the US Department
of State, DHA, TOPO, US military operational leaders and executives are always positive and consistent
with the contractual obligations.
• Participate in appropriate social, professional, and networking events which assist International SOS
with strengthening the DoD relationship in the region.
• Facilitate development of close and constructive working relationship between the MTFs, other
government stakeholders, and the Near Patient team

Medical Service Delivery (TRICARE)
• Ensures that all operational delivery of TOP medical services and patient care across the region
coordinated by the medical team meet the appropriate standard of medical quality in accordance with
the TOP Clinical Quality Medical Plan (CQMP), DHA service level expectations and Assistance Center
and Medical Transportation Standards.
• Assists the Head of Clinical Quality with feedback on PCSP and gathering of clinical information that
contributes to the Clinical Quality ratings
• Ensures that all KPIs for the delivery of Remote medical services within the area of responsibility are
met

Medical Transportation Services (TRICARE)
• Through the TOP Medical Team leadership, ensure adherence to Intl. SOS Standards in Medical
Transportation for all medical transportation carried out by or supervised by the Assistance Center for
TOP beneficiaries across the region.

Quality Assurance
• Working together with the Near Patient Regional Medical Director and the Pacific Clinical Quality
Assurance Leads to support quality assurance regarding the provision of all TOP medical services
delivered by the Near Patient Program for their AOR, including adherence to client quality plan indices
(in particular the CQMP), case audit and review service recovery, assessment of near misses,
grievances, Potential Quality Incidents (PQIs) and Quality Incidents (QIs).
• Support and monitor Corrective Action Plans and a structured implementation of measures to further
enhance the delivery of services as a result.

Global Assistance Network (GAN)
Work closely with the Head of Clinical Quality and associated staff to ensure prioritization of TOP network
development focus in the region providing key provider relationship development in keeping with the contract
requirements and client feedback.
• To visit designated TRICARE locations across the region as required liaising with MTF
Commanders, staff, and medical providers.
• May assist in validation of scope, quality, and credentialing of TOP medical providers in accordance
with DHA mandated requirements.

Management and Administration
• Facilitate effective positive teamwork and clear channels of communication both internally and
externally.
• Provide positive and negative feedback on NPT work.
• Set clear standards, action plans and yearly performance appraisals for functional reports.
• Input and play an active role in overseeing medical staff succession planning and development
programs.
• Respond to requests for information from the client that are cleared by International SOS.
• Assist with the maintenance of the Statement of Responsibility.
• Provide oversight of MTF Huddles for the area of responsibility.
• Assist in creating an environment in the NPT that promotes process improvement and open
communication.

Additional Responsibilities
• Work flexible hours as appropriate to the needs of the position.
• Undertake transmission and first-call responsibilities as required
• To participate and prepare for designated TRICARE meetings, quality and case reviews and annual
audits, as operationally required.
• Assist with the training of new Near Patient staff
• Work within and promote all International SOS’s policies, procedures, and corporate values.
• Be aware of Intl. SOS’ OH & S policies, practices and procedures and actively participate in the
ongoing development and enhancement of these important areas of our business.
• Undertake project work or reasonable duties as requested by direct Managers.
• Maintain medical license and up-to-date passport.
This job description outlines the general ways in which it is expected you will meet the overall requirements of
this post.
The list of tasks is not an exclusive one and duties may be varied from time to time. This job description is
subject to regular review.