Japan Project Physician/臨床開発医師 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2018年 04月 23日
春の転職支援キャンペーン 期間:2018年1月26日(金)から4月30日(月)

求人情報

臨床開発医師

求人管理No.012025

会社概要

Japan Project Physician

外資製薬メーカーにて臨床開発を主導する医師の募集。

募集要項

Description:
Project Physician (PP) is a medical expert who is accountable/responsible for the medical science expertise to generate clinical development strategy, design clinical development options, and deliver successful clinical development of responsible products in Japan. PP is working closely with Medical Scientist (MS). His/Her accountability/responsibility is mainly project-level, however, he/she is also involved in study-level activities as needed.

1 Project Level
1.1 Design & Interpretation / D&I
1.1.1 Lead D&I activities to generate Japan clinical development strategy with MS and ensure that Japan medical science views are appropriately incorporated in project development strategy
1.1.2 Generate high-quality design options that characterize benefit, risk and value of medicinal products, focusing on reducing uncertainties and providing clear and transparent recommendations for decision and governance bodies.
1.2 Planning
1.2.1 Ensure and champion consistent clinical science aspects and strategies across programs.
1.2.2 Ensure optimal management of high impact project opportunities and risks.
1.2.3 Review study design, regulatory documents consistent with the clinical strategy.
1.2.4 Ensure delivering rationalized hypothesis, evidence based argument, and convincing interpretation in clinical science related documents.
1.2.5 Input scientific information to internal documentation/slides such as IDP/CDP and governance document.
1.3 PMDA interaction
1.3.1 Co-develop clinical science part of regulatory related documents with MS; e.g., PMDA consultation BD, query responses, etc., and ensure the consistency with agreed clinical strategy and medical science aspects are captured properly.
1.4 JNDA
1.4.1 Review CTD and ensure the consistency with agreed clinical strategy and medical science
aspects are captured properly.
1.5 Pharmacovigilance (PV)
1.5.1 Evaluate the safety data, describing industry’s views for patient safety in CTD preparation, and
point out information required for safety narrative and DSUR.
1.6 KEE management
1.6.1 Lead key contacts with external experts and help develop clinic-scientific alliance working with
MS and global CPT.
1.6.2 Act as a key point of contact for clinical science related relationship with external experts.

2 Study Level
2.1 Planning
2.1.1 For Japanese standalone studies including regulatory required post-marketing studies, lead
development of clinical science part of clinical trial documents with MS, e.g., study specification,
clinical study protocol.
2.1.2 For global leading studies including Japan, review the document and ensure that medical
scientific feasibility and ethical integrity in Japan is appropriately incorporated.
2.2 Execution
Act as a study physician of Japan standalone studies as well as support global study physicians of
global leading studies to care for the following tasks:
2.2.1 Provide clinical science support such as eligibility criteria, efficacy and safety data review to
specific studies for risk mitigation.
2.2.2 Ensure the medical/scientific accuracy in following documents:
2.2.2.1 CSPs (incl. Master Informed Consent Form) and CSRs.
2.2.2.2 IND and responses to Regulatory Authority.
2.2.3 Approve following documents as a study physician:
2.2.3.1 Study specification (SS), Clinical Study Protocol (CSP) and Clinical Study Report
(CSR)
2.2.3.2 (if applicable) Japan specific part of Investigator Brochure (IB)
2.2.3.3 Medical contents of Case Report Forms (CRFs).
2.2.4 Lead discussion at Investigators’ meeting.
2.2.5 Lead executing GPRMP for clinical studies.
2.2.6 Provide clinic-scientific leadership to non-interventional study planning and reflect results on
Japan D&I activities.
2.2.7 Provide clinic-scientific leadership and support ESR in Japan.
2.3 Publication
2.3.1 Input to publication strategy and contents/quality of publications

3 Collaboration with Marketing company
3.1 Input scientific and medical perspectives into Japan commercial, pricing and medical strategy for
product value maximization

4 Others
4.1 Compliance to company rules and external regulations
4.1.1 Ensure that own work and all work within TA is performed in accordance with appropriate SHE
and Compliance standards.
4.2 Tasks outside projects
4.2.1 Assumes other duties as assigned by the Medical Science Director

Feeder roles:
・The person who meets the requirements above
Measures of Success:
・The context of clinical science input, including scientific risks, mitigations and setting right
expectation of clinical development POS, is properly understood by the internal governance
bodies for their quality decisions and by the internal stakeholders for the engagement.
・Optimum clinical science strategy is provided for optimum market access of the products within TA
portfolio
Education and Experience
Education and Degree
・Medical Doctor degree required
Education and Experience
・Doctor of Philosophy preferred
Experience
・Clinical practice as physician
・Planning of clinical development strategy and execution of clinical trials
・Negotiations with external experts and authorities
・Getting JNDA approval and supporting launch activities
Skills and Capabilities
Communication-related
・Communication skill
・Interview skill
・Negotiation skill
・Logical thinking
・Writing skill
・Presentation skill
Team working-related
・Meeting management
・Facilitation skill
・Project management
Reporting Relationship / Team Membership:
・Report to TA Medical Science Director
・Direct reports: None
Signed

募集条件

  • Education and Experience
    Education and Degree
    ・Medical Doctor degree required
    Education and Experience
    ・Doctor of Philosophy preferred
    Experience
    ・Clinical practice as physician
    ・Planning of clinical development strategy and execution of clinical trials
    ・Negotiations with external experts and authorities
    ・Getting JNDA approval and supporting launch activities

    Skills and Capabilities
    Communication-related
    ・Communication skill
    ・Interview skill
    ・Negotiation skill
    ・Logical thinking
    ・Writing skill
    ・Presentation skill

    Team working-related
    ・Meeting management
    ・Facilitation skill
    ・Project management
    Reporting Relationship / Team Membership:
    ・Report to TA Medical Science Director
    ・Direct reports: None

勤務開始日

  • 応相談

採用人数

  • 若干名

雇用形態

  • 正社員

勤務地

  • 東京・大阪

転勤有無

  • 当面なし

勤務時間

  • フレックスタイム制(標準労働時間7時間15分)

給与

  • ご経験に応じての額となります。