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Clinical Science Lead

年収:1500万 ~ 2000万

ヘッドハンター案件

特集求人

本求人は、「プレミアムステージ」をご利用でなくても、ビズリーチ会員であればどなたでも閲覧、応募が可能です。
部署・役職名 Clinical Science Lead
職種
業種
勤務地
仕事内容 For the assigned program/project(s) in the region with support by function head / seniors:

Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work.
Drive the development of Clinical Development Plan (CDP) and relevant study designs through team effort; ensure input from internal or external expertise is integrated and reflected in the CDP. Such expertise may include but not limited to key opinion leaders, global Patient Value Unit, regulatory affairs experts, project/study physicians, project management, biostatisticians, and pharmacologists.
Be responsible for overall implementation of the CDP to ensure timelines, budget as well as deliverables are within expectation.
Co-author and/or review protocol concept / protocol, other study-related clinical documents according to the CDP, and scientific publications.
Ensure that medical science is well incorporated into the clinical development strategy, plans and study designs.
Guide the team through data analyses and review to conclude for study result interpretation.
Serve as the leader in logic construction in clinical for various submissions across the region, such as CTD/eCTDs, CTAs/CTNs and NDAs or IDLs.
Support to establish “Center of Excellence” in clinical development in Asia.
[If the person is M.D. and it requires]

Oversight CRO's medical monitoring activities and educate medical monitors
Contribute to safety evaluations to ensure participating patients’ safety in clinical studies.

【Major Accountabilities】
For the assigned program/project(s) in the region with support by function head / seniors:
Lead the Development Team, including but not limited to: stakeholder management, team alignment, team meeting and communication, team goal setup and deliverable status check, collaborate with other project teams such as EDT, JCST, ST.
Work with the team and stakeholders to develop CDP for the region/country.
Contemplate study design for each clinical trial and prepare study concept according to the CDP.
Ensure the best medical science parts are incorporated into the CDP of the assigned clinical program/projects, including study design discussion, protocol concept / protocol development, and other related documents.
Oversee the ongoing evaluation of study efficacy/safety and data quality, effectively and efficiently interact with partners, key opinion leaders and investigators.
Drive the implementation of the CDP for timeline, budget and deliverables; provide technical guidance to the operational team when needed; identify potential risks and manage any challenges that may occur.
Lead the team in data analyses and result interpretation for studies.
Main responsible person at meetings with Regulatory Authorities and/or partners as necessary.
Main responsible person at conferences and meetings with Key Opinion Leaders as necessary.
Ensure compliance of program/project(s) with all appropriate regulations, SOPs, company processes and ICH-GCP and quality standard applicable to us.
Construct the submission logic for clinical part of CTD/eCTD and any other regulatory documents.
Lead and drive clinical part of submission team to establish quickest time from LPLV to NDA.
労働条件 【給与】年俸制 ※経験・能力等を考慮の上、決定
    成果に応じて昇給あり(年1回)
    通勤交通費別途支給

【福利厚生】
退職年金・団体生命保険・定期健診・各種社会保険・財形財蓄制度
永年勤続表彰・クラブ活動・英語学習補助

【休日休暇】
週休2日制(土・日)
祝日・夏季休暇・年末年始休暇・有給休暇・慶弔休暇・特別休暇

【勤務時間】
9:30-18:00
フレックスタイム制 (コアタイム無し) 7.5h×月間所定労働日数で清算
昼休み 1時間

屋内禁煙
応募資格

【必須(MUST)】

Japanese Medical Doctor (Foreign license is considerable) is preferable , but not a must
Understand and apply scientific principles to clinical development strategy / trial design as well as data acquisition, analyses, and reporting. Apply fair balance in data interpretation.
Depending on previous professional experience, more than 3 years of relevant experience in biopharmaceutical-clinical development (or equivalent) is required including the followings:
Oversight of the planning and simultaneous management and reporting of multiple clinical studies.
Broad experience in writing and/or participation in the preparation of submission documents required (across or at timepoints along the continuum from original protocol to NDA/PLA to safety updates).
Experience in critical review of relevant development and regulatory documents outside the clinical arena preferred.
Current knowledge of most aspects of the global clinical development processes / global studies required.
The knowledge of relevant therapeutic area preferred.
Actual experiences for authorities' consultation, authorities' review and negotiation processes to obtain approval are also preferable

更新日 2021/09/02
求人番号 1868680

採用企業情報

  • ベルギーのブリュッセルに本社を置く製薬メーカー
  • 会社規模101-500人
  • 会社概要

    ベルギーのブリュッセルに本社を置くグローバルバイオファーマで、ニューロロジーや免疫・炎症領域の重篤な疾患と共に生きる患者さんのより良い生活の実現を目指して、革新的な医薬品の研究開発や創薬ならびに ソリューションの提供に力を注いでいます。
    世界約40か国に拠点を置き、従業員数は7,500名以上です。

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