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Medical Director / Associate Director, MPD Clinical Science

Medical Director / Associate Director, MPD Clinical Science

TakedaTokyo, Japan
15 days ago
Job description

Description

OBJECTIVES :

  • The Medical Director of MPD Clinical Science in Osaka (MDMP in Osaka) is accountable for Sponsor clinical and medical oversight for assigned marketed products globally including Japan as well as Japan-specific products within MPD remit. Participates in new business evaluation. Usually responsible for multiple products.
  • The MDMP in Osaka is an integral member of the Marketed Products Development (MPD) that is responsible for providing dedicated R&D support for the products under its purview. The MDMP interacts and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance, global development operations and project management) to set R&D strategy and prioritise and deliver R&D functional support for assigned MP portfolio, that is aligned with the broader business objectives for the portfolio. This individual is responsible for medical and clinical scientific leadership and execution for the assigned products on the specific global program teams (GPT), the product support teams (PST) or the established product inspired collaboration (EPIC) oversight team .
  • The MDMP provides Sponsor clinical and medical Oversight and support for assigned products as part of the dedicated, integrated R&D support to ensure the ability of Takeda to meet its corporate obligations as MAH for assigned products. The MDMP provides medical and clinical leadership to anticipate potential compliance risks, and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
  • The MDMP will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance, mentoring and leadership across these areas.
  • MPD クリニカルサイエンス メディカルディレクター（以下、大阪所属のMDMP）は、担当する日本を含む全世界で市販されている製品及び日本固有の製品に対して、臨床及び医学的観点から監視・監督する責任を負う。通常、複数の製品を担当する。
  • MDMPは、Marketed Products Development（MPD）の構成員であり、その管轄下にある製品に対し、臨床開発サポートを提供する責任を負う。MDMPは、担当する市販後製品ポートフォリオに対して、市販後製品を担当する各R&D部門リード（薬事、安全性部門、グローバル開発オペレーション、及びプロジェクトマネジメント）と連携し、臨床開発戦略の策定、及び臨床開発の実行をサポートする。特定のGlobal Program Team（GPT）、Product Support Team（PST）、又はEstablished Product Inspired Collaboration（EPIC）Oversight Teamにおいて、担当製品に関する医学的及び臨床科学的なリーダーシップを提供し、計画を実行する責任を負う。
  • MDMPは、担当製品に対し、担当製品のMAHとして、及び治験依頼者としての臨床的及び医学的な監視及びサポートを提供する。MDMPは、潜在的なコンプライアンスリスクを予測すべく、医学的及び臨床的リーダーシップを発揮し、適切な緊急時対応計画を作成、管理する。
  • MDMPは、担当製品における医学的及び臨床科学的な専門家であり、これらの領域全般で医学的、臨床的及び科学的なサポート、ガイダンス、メンタリング及びリーダーシップを提供するために、製品の科学的、医学的及び薬事的側面に関する最新の専門知識を習得し、維持することが求められる。

ACCOUNTABILITIES :

The Medical Director of MPD Clinical Science in Osaka will be responsible for, and participate in the following activities :

Marketed Product R&D support & Leadership

  • Partner with MPD Global Project Management to coordinate R&D function support for assigned products within the GPT or PST or products under EPIC portfolio. Provide medical and clinical scientific leadership, expertise and execution for assigned products to support other R&D function leads within the team.
  • Establish integrated partnership(s) with R&D functional leads on assigned team (regulatory affairs, pharmacovigilance, global development operations).
  • Collaborates with the commercial organizations to achieve team objectives
  • Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders to support assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
  • Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Global Project management (GPM) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities / studies across assigned products. Works effectively to support GPT / PSTs.
  • Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for assigned products. Ensure highest quality of medical / clinical science input and clinical components of deliverables from the strategic partner vendor.
  • Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation / approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides Takeda oversight of strategic partner MDs / clinical staff involved in these activities. Accountable for the successful design, execution and interpretation of clinical studies.
  • Oversees the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, to ensure appropriate benefit / risk of subjects within the study. Responsible for internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and / or individual subject benefit / risk. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity
  • Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
  • Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective
  • Presents study conclusions to management and determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients
  • Participate in and support all required regulatory submissions / interactions for assigned products. Represent Takeda as Responsible Medical Doctor and Medical / Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical staff for regulatory agency interactions for assigned products, as needed. Drive and execute medical and clinical scientific input and development of required documents for regulatory applications / submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
  • Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community)
  • Oversee compliance with internal SOPs and external legal requirements, including training of assigned personnel, contractual arrangements with external service providers and partner companies.

    • Japan specific product R&D support & Leadership

  • Japan Development team (JDT) team leader and an expert of Clinical Science in JDT for the assigned marketed product or the assigned Japan specific newly developing product. Provide medical and clinical scientific lead as well as exerting leadership as a JDT team leader in conducting and promoting clinical activities of the team partnering with Project Management.
  • Establish integrated partnership(s) with R&D functional leads on assigned JDT such as regulatory affairs, pharmacovigilance, clinical operations, stats and with strategic partner vendor(s).
  • In collaboration with Japan Business Unit (JPBU), exerts leadership from the aspect of Clinical Science in conducting and promoting clinical activities including life-cycle management to maximize the value of the assigned product(s).
  • Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Japan Medical Office.
  • As a manager in MPD clinical science, provides advice to his / her direct report(s) on the task management, career development, education, etc.

    • External Interactions

  • Build and develop medical and clinical expert relationships to ensure delivery and maintenance of state-of-the-art medical therapeutic and clinical scientific expertise into medical and clinical R&D support for assigned marketed products
  • Participates in meetings with regulatory agencies as required
  • Represent Takeda on external bodies as needed.

    • Due Diligence, Business Development & Alliance Projects

  • Participate and conduct clinical due diligence evaluations and development of clinical development plans for potential alliances and or in-licensing opportunities.
  • Assess both scientific and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner / acquisition companies during due diligence visits and alliance negotiations, and actively participating on internal assessment teams in conjunction with commercial colleagues.

    • MPD クリニカルサイエンスメディカルディレクターは、以下の業務に対して責任を持ち、実施する

  • MPD グローバルプロジェクトマネジメント（GPM）と連携し、GPT又はPSTの担当製品又はEPICポートフォリオの製品に対する臨床開発のサポートを提供する。チーム内の他のR&D部門リードを支援するために、担当製品に関する医学的及び臨床科学的観点からリーダーシップ、専門知識を提供する。
  • R&D部門リード（薬事、安全性部門、グローバル開発オペレーション）との統合的なパートナーシップを構築し、部門横断的に関連する全てのステークホルダーと協力する。このステークホルダーには品質保証部門、製造・生産部門、メディカルアフェアーズ部門、コマーシャル部門などが含まれる。これらのステークホルダーと協力してチームの目標達成をクリニカルサイエンスの観点からリードする。
  • GPL）及びGPMと統合的なパートナーシップを構築し、協力して、担当製品全般に関する臨床サポートの提供及び臨床開発活動 / 臨床試験を実施する。
  • LCM、市販後要件及び地域又は日本での承認を支援するため、治験実施計画書の作成・承認及び臨床試験の実施に関連する臨床開発活動をリードする。戦略的パートナーである医学専門家や外部の臨床スタッフと連携して臨床試験及び解析等を実施し、その科学的妥当性、品質を担保する。
  • ICHの遵守を保証する。
  • R&D業務以外に，部門横断的なプロジェクトや活動（例：企業文化の浸透、DE&I、業界活動、等）に参加する。
  • Local Operating Company（LOC）のメディカル / 臨床スタッフを支援する。規制当局への申請 / 提出に必要な文書（例：試験概要の報告、CTD、INDの更新、PSURの更新、添付文書の変更、等）、会議でのプレゼンテーションに使用される資料、及び規制当局から受領した通知に対する正式な回答の作成を推進し、医学的及び臨床的・科学的インプットを提供する。
  • SOP及び外部の法的要件の遵守を監視する。
  • Japan Development Team（JDT）チームリーダー及びJDTのクリニカルサイエンスの専門家としての責任を負う。臨床開発のクリニカルサイエンスに関する業務及び協議全般をリードするとともに、JDTチームリーダーとして、プロジェクトマネジメントと連携してチームの臨床開発の実施及び推進にリーダーシップを発揮することが求められる。
  • JDTにおけるR&D部門のリード及び提携ベンダーとの良好なパートナーシップを確立し、維持する。
  • Japan Business Unit（JPBU）と連携し、担当製品の価値最大化に向けたライフサイクルマネジメントを含む臨床活動の実施・推進をクリニカルサイエンスの側面から支援する。
  • MPDクリニカルサイエンスのマネジャーとして、部下のタスク管理、キャリア開発、教育等に関する助言を行う。

    • EDUCATION, EXPERIENCE AND SKILLS ：

  • MD or internationally recognized equivalent plus 3~6 years of clinical research experience within the pharmaceutical industry, CRO, health-related consulting company, or biomedical / clinical experience within academia or clinical practice (or a combination of afore mentioned).
  • Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
  • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals
  • NDA / MAA / Submission experience preferred

    • Skills

  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities across multinational business cultures

    • Knowledge

  • Regional / global Regulatory requirements
  • GCP / ICH

    • LANGUAGE AND OVERSEAS WORK EXPERIENCE ：

  • English skill is required to use without problem in business and discussion with global employees
  • Fluency in Japanese required
  • Working experience in a global team or environment is preferable.

    • BEHAVIOURAL COMPETENCIES :

  • Strong written and verbal Communication Skills : ability to communicate complex information in a clear and engaging manner. ability to inspire commitment through a wide range of communication channels (meetings, writings, presentations)
  • Establish productive relationships and partners with others across the organization : ability to reinforce open dialogue and exchange of perspectives through a variety of methods (meetings, conference calls, cross-functional teams, etc.). ability to cultivate a broad network of relationships throughout Takeda, with affiliates and alliance partners.
  • Leadership skills : ability to understand differences in practices across organizations or countries, and balances local demands and perspectives with global strategies ability to make key decisions with an effective combination of thoughtful analysis, buy-in and speed
  • CRO等で6年以上の臨床開発経験を有する方（Associate Meical Directorの場合は3年以上）
  • 1 : 1等）を通じて開かれた対話と意見交換を図り、意思決定を推進する能力
  • GCP / ICH及び日本やグローバルの医薬品開発に関する規制要件を熟知している
  • 8日以上、大阪・東京本社での勤務が可能な方

    • Takeda Compensation and Benefits Summary :

    Allowances : Commutation, Housing, Overtime Work etc.

    Salary Increase : Annually, Bonus Payment : Twice a year

    Working Hours : Headquarters (Osaka / Tokyo) 9 : 00-17 : 30, Production Sites (Osaka / Yamaguchi) 8 : 00-16 : 45, (Narita) 8 : 30-17 : 15, Research Site (Kanagawa) 9 : 00-17 : 45

    Holidays : Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

    Paid Leaves : Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

    Flexible Work Styles : Flextime, Telework

    Benefits : Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

    Important Notice concerning working conditions :

    It is possible the job scope may change at the company’s discretion.

    It is possible the department and workplace may change at the company’s discretion.

    Locations

    Osaka, JapanTokyo, Japan

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

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