求人詳細
| 非公開求人 大阪府 | |
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2024.10.28 更新
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Medical Director, MPG Clinical Scienceのご勤務／大阪市内
大手内資系製薬メーカーでの就業です。
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| 募集背景 | 体制強化のため、一般内科医師を募集しております。大手内資系製薬メーカーにて、Medical Director, MPG Clinical Scienceのご勤務となります。 |
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| 勤務内容 2024.10.28更新 | |
| 募集科目 | 一般内科 |
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| 日勤の仕事 |
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| 備考 | 【勤務内容の詳細】 OBJECTIVES: The Medical Director of MPG 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 MPG remit. Participates in new business evaluation. Usually responsible for multiple products. The MDMP in Osaka is an integral member of the R&D Marketed Products Group (R&D MPG) 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 prioritize 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) or established product sub teams (EPST), 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. ACCOUNTABILITIES: The Medical Director of MPG Clinical Science in Osaka will be responsible for, and participate in the following activities: Marketed Product R&D support & Leadership Partner with R&D Marketed Product Project Manager to coordinate R&D function support for assigned products within the GPT or EPST. 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 organization and Established Products Team and Sub Teams 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 Established Product Sub Team Project manager (EPST 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/EPSTs. 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 Affairs. As a manager in MPG 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 〇〇 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. 【必須条件】 ・臨床経験6年以上 ・TOEIC800点以上 【歓迎スキル】 ・PhD保有 ・留学経験 ・治験（臨床研究等）の知識 【その他】 ・休日：週休2日(土・日)、祝祭日 ・休暇：土曜、日曜、祝日、メーデー、年末年始など（年間123日程度） 年次有給休暇、特別有給休暇、リフレッシュ休暇、産前産後休暇、育児休暇、介護休暇、フィランソロピー休職制度 ・契約期間：期間の定めなし ・試用期間：あり（3か月） ・時間外労働：あり ・加入保険：社会保険／健康保険、厚生年金保険、労働保険／雇用保険、労働者災害補償保険" ※記載の件数等は目安の数字です |
| 勤務日時 2024.10.28更新 | |||
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| 勤務条件 2024.10.28更新 | ||||
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| 契約期間 | 契約期間の定め | |||
| 試用期間 | 試用期間の定め | |||
| 退職に関する事項 | 定年制 | |||
| 継続雇用制度 | ||||
| 自己都合退職に関する手続き | ||||
| 解雇の事由および手続き | ||||
| 受動喫煙対策 | 対策 | |||
| その他 | 雇用期間 有期 ※個別相談の可能性有/試用期間 有り ※個別相談の可能性有 | |||
| 勤務場所 2024.10.28更新 | ||
| 所在 |
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| 施設 |
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| 募集要項 2024.10.28更新 | |
| 提出書類 | なし |
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| 選考方法 | 面接あり |
| 照会先 |
■Dr.なび運営会社 株式会社エムステージ 医師担当コンサルタント宛て □連絡先 東京本社 TEL：0120-148-506 Email：cp@mstage-corp.jp 東京都品川区大崎2-1-1 ThinkPark Tower 5F https://www.mstage-group.jp/ |
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