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Latest Jobs

5 listing(s) available.

  • 20 Dec 2018

    クリニカルサイエンティスト

    Japan

    Permanent Position
    MSDは、グローバルヘルスケアリーダーMerck & Co., Inc., Kenilworth, N.J., U.S.A.の一員として、日本の皆さまに医療用医薬品やワクチンをお届けし、革新的なヘルスケア・ソリューションを提供しています。強固なパイプラインと世界140カ国以上で事業を展開するグローバルなネットワークを活かし、未だ満たされていない日本の医療ニーズに積極的に応えていきます。

    Job Description

    糖尿病、循環器、ワクチン、感染症、中枢神経、呼吸器・免疫・骨領域のいずれかの疾患領域について、クリニカルリーダーと協働して以下の業務を担当する:
    ・開発戦略策定
    (早期及び後期開発計画書への日本での臨床開発に関するインプット)
    ・開発戦略に基づいた機構相談の立案、資料の作成、及び照会事項に対する回答作成
    ・治験実施計画書の立案及び作成
    -ローカル試験(試験骨子から作成)
    -グローバル試験(日本で実施するための計画書の適性化)
    -米国本社や海外ベンダーへの説明、交渉を含む
    ・同意説明文書(会社案)の作成
    ・治験実施計画書に関連する資料(症例報告書、関連手順書、等)の作成サポート及びレビュー
    ・治験データメディカルレビュー
    ・治験総括報告書及び承認申請資料(CTD)臨床パートの作成(メディカルライターと協働)及びレビュー
    ・学会発表、論文作成及びそれらのサポート
    ・開発関連部門との連携により臨床試験実施の中心的役割を担う

    The following responsibilities are to be fulfilled by the candidate in one of the therapeutic areas including diabetes, cardiovascular, vaccines, infectious diseases, neuroscience, respiratory immunology and bone : 
    ・Formulate development strategies
    (Provide input on clinical development in Japan for early and late phase development plans)
    ・Make plans for PMDA consultation meetings based on the development strategy, prepare materials, and respond to inquiries from health authorities
    ・Plan and develop clinical trial protocols
    -Local Studies(Start with drafting of study synopsis)
    -Global Studies(Optimize protocols for studies to be conducted in Japan)
    -Including explanation to, and negotiations with the US headquarters and overseas venders
    ・Develop Informed Consent (Company Draft)
    ・Provide support for development and review of study protocol related materials (e.g. CSR, SOP,etc.)
    ・Perform medical review of clinical trial data
    ・Develop (in collaboration with medical writers) and review Clinical Study Reports (CSRs) and the clinical section of the Common Technical Document (CTD)
    ・Make presentations at scientific meetings and author manuscripts, or provide necessary support 
    ・Assume a central role in the conduct of clinical trials in cooperation with the relevant departments

    Expires on 14 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    必要とする資質:
    ・医薬品臨床開発業務の経験(5-15年)
    ・治験実施計画書の作成経験
    ・社内(国内・外)関連部門及び外部専門医との密接な協働作業のためのコミュニケーションスキル
    ・TOEICスコア730以上に相当する英語力
    ・薬学あるいは生命科学に関する専門知識
    望ましい資質:
    ・CTD作成、治験総括報告書作成、承認取得、CRA業務
    ・以下の疾患領域の開発経験:糖尿病、循環器、ワクチン、感染症、中枢神経、呼吸器・免疫・骨領域
    ・早期臨床試験の立案及び実施(Study management)の経験があれば尚可

    Required Skills and Abilities:
    ・Work experience in drug development (5-15 years)
    ・Experience in development of clinical trial protocols
    ・Good communication skills essential for a close collaboration with internal (Japan and ex-Japan) relevant departments and external experts
    ・English level equivalent to TOEIC score above 730
    ・Specialized knowledge in pharmacy and life science
    Preferred Skills and Abilities:
    ・CTD development, CSR development, obtainment of JNDA approval, CRA/Monitor experience
    ・Work experience in the development of the following therapeutic areas: diabetes cardiovascular, vaccines, infectious diseases, neuroscience, respiratory immunology and bone 
    ・Experience in the planning and execution of early phase clinical trials(Study management)is preferred

  • 20 Dec 2018

    Associate Director, Medical

    Japan

    Permanent Position
    「深く思いやり、人生を変える」という当社のコミットメントを実現するために、国内に必要な機能を持つ組織を築きあげ、当社の革新的な医薬品を日本の患者さんに確実に提供することに注力しています 。 神経疾患、自己免疫疾患、希少疾患の治療法開発に重点を置く、世界屈指のバイオテクノロジー会社です。1978年に設立され、生物学的および低分子薬の発見における当社の研究が、世界で最も広範な多発性硬化症治療法のポートフォリオと、血友病患者さんのための革新的な新しい治療法へと導きました。革新における経験、能力、熱意によって、当社はパイプラインを築き上げ、重篤で治療が困難なアルツハイマー病、脊髄性筋萎縮症、筋萎縮性側索硬化症(ALS)のための可能性ある治療法の探索を含む 最先端の研究プログラムを推進しています。 当社は複雑な疾患の根底にある、生物学的なメカニズムの研究に尽力しています。当社は治療オプションが、たとえあるとしても非常に少ない疾患に重点を置いています。私達の成功は、常に次のシンプルな質問への回答によって評価されます。 【患者の方々の生活に真の違いをもたらしたか?】

    Job Description

    This job is required to run AD medical activities with close collaboration with external counterparts (E
    Medical and Market team) as well as internal counterparts .
    The person should be able to manage AD team with sufficient communication skills with various internal
    and external stakeholders including External counterparts. This person will be the primary medical contact to
    External teams.
    1. As a Medical Lead for Alzheimer Disease, the person conducts medical team and oversees various
    medical activities.
    2. Plan and manage medical activities (pre and post-launch) under close collaborations with global medical, clinical
    development (including current/future pipelines), and External teams.
    3. Analysis of current/future medical status in Japan for aducanumab indication/treatment aligned with the global
    strategies, and provide medical information to Market team for establishment of interactive company-External pre-launch and post-launch activities.
    4. Planning and execution of various medical education activities including congress activities, advisory board meetings
    via active communication/engagement with KMEs and the External Medical team.
    1. Make medical activity and budget plan with internal and external counterparts.
    >AD Medical and Commercial teams
    2. Lead AD Medical team with close communication with internal and external counterparts.
    >AD Medical Director
    3. Close collaboration with external counterparts
    >Our Japan Medical and E Japan Medical
    4. Lead communication to the global Medical team
    >Japan Medical team
    5. Plan and oversee congress and associated medical activities
    >AD Medical and Commercial teams

    Expires on 14 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    MD/PhD level academic degree or professional degree, such as RN または同等の知識をお持ちの方
    At least 2-year experience in working at industry 

  • 20 Dec 2018

    Clinical Development Associate Director

    Japan

    Permanent Position
    「深く思いやり、人生を変える」という当社のコミットメントを実現するために、国内に必要な機能を持つ組織を築きあげ、当社の革新的な医薬品を日本の患者さんに確実に提供することに注力しています 。 神経疾患、自己免疫疾患、希少疾患の治療法開発に重点を置く、世界屈指のバイオテクノロジー会社です。1978年に設立され、生物学的および低分子薬の発見における当社の研究が、世界で最も広範な多発性硬化症治療法のポートフォリオと、血友病患者さんのための革新的な新しい治療法へと導きました。革新における経験、能力、熱意によって、当社はパイプラインを築き上げ、重篤で治療が困難なアルツハイマー病、脊髄性筋萎縮症、筋萎縮性側索硬化症(ALS)のための可能性ある治療法の探索を含む 最先端の研究プログラムを推進しています。 当社は複雑な疾患の根底にある、生物学的なメカニズムの研究に尽力しています。当社は治療オプションが、たとえあるとしても非常に少ない疾患に重点を置いています。私達の成功は、常に次のシンプルな質問への回答によって評価されます。 【患者の方々の生活に真の違いをもたらしたか?】

    Job Description

    Job Function
    • The position of Associate Director in Clinical Development will support one or more development programs in Japan. The
    individual who assumes this position will function as a scientific and clinical development lead in areas of strategic interest
    to our development pipeline. The individual will interact with multiple levels of management within company,
    external stakeholders in the medical community, along with global regulatory authorities to provide strategic leadership for
    Japan clinical development planning/execution based on in-depth knowledge of therapeutic areas and extensive
    experiences in clinical development. The candidate should be a driven and innovative builder who has strategic mindset in
    the therapeutic area and implemented those well.
    Job Responsibilities
    • Medical and/or scientific lead for Japan local studies; for global studies, provide medical/scientific support to headquarter
    study medical director to ensure appropriate incorporation of Japan specific elements (e.g. unique therapeutic area
    element, biomarker development) into study design and implementation. Thus has direct responsibility for advancing high
    priority clinical programs through clinical study design and execution, as well as interpretation of data from key clinical
    studies.
    • Work closely with Japan/global study team to provide strategic support for clinical operation; Support study site visits and
    responsible for discussion/education on scientific and medical matters with investigators/site staff
    • Contribute to Japan regulatory strategy discussion, lead medical and scientific discussion from our with Japanese
    regulatory agency (PMDA)
    • Be the Japan clinical development/scientific lead for registration filings in Japan
    • Clinical Development Plan (CDP): accountable for Japan clinical development strategy
    o Work closely with Japan program management team to integrate the scientific rationale, regulatory requirements,
    operational feasibility, product development plan, and commercial goals to build a solid strategic framework for
    the Japanese components of the CDP.
    o Lead clinical development strategy discussion
    o Ensure that each program’s Japanese strategic plan is fully aligned with the global strategy and is fully understood
    by the Programs team
    • Continue to expand therapeutic knowledge in relevant areas, attend major scientific conferences to establish and maintain
    scientific collaboration with Japanese KOL physicians with consensus and alignments with global team and Japan
    • Develop and maintain collaboration with program counterparts within R&D and Japan Medical and business unit teams
    • Report to the Head of Japan clinical development and provide support to ensure overall alignment in Japan R&D strategy
    • Contribute to the development of strategic initiatives, specific Business Development activities and overall medical lead for
    various organizational initiatives in Japan R&D
    • Contribute to overall development of company, support engagement with external steak holders/collaborators
    including government agencies, pharma-biotech industry groups, academic/physician association, and patient advocacy
    groups.

    Expires on 14 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    Job Requirements
    Experience
    • Clinical development experience within in biopharmaceutical industry (at least 3 years in product development), focusing in
    at least one area of our’s focusedneurology therapeutic areas (e.g Neurodegenerative diseases such as
    Dementia/Alzheimers, ALS,; Stroke, etc)
    • Experience working with regulatory agencies (PMDA experience preferred)
    • Ability to lead scientific discussion on mechanisms of new research approaches, clinical endpoints, protocol design, or data
    interpretation
    • Established or has ability to establish peer level relationships with therapeutic area opinion leaders worldwide
    11/03/1811/08/17
    • Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment
    • Demonstrated strategic and critical thinking
    • Excellent communication skills (oral and written) and excellent organizational skills
    • Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills
    Educations
    • MD, MD/PhD or PhD
    • Specifically strong clinical credentials and/or drug development experiences in the therapeutic areas combined
    with strong grounding in scientific research 

  • 20 Dec 2018

    Assoc Medical/Scientific Director, Clinical Development, Japan Clinical Development

    Japan

    Permanent Position
    「深く思いやり、人生を変える」という当社のコミットメントを実現するために、国内に必要な機能を持つ組織を築きあげ、当社の革新的な医薬品を日本の患者さんに確実に提供することに注力しています 。 神経疾患、自己免疫疾患、希少疾患の治療法開発に重点を置く、世界屈指のバイオテクノロジー会社です。1978年に設立され、生物学的および低分子薬の発見における当社の研究が、世界で最も広範な多発性硬化症治療法のポートフォリオと、血友病患者さんのための革新的な新しい治療法へと導きました。革新における経験、能力、熱意によって、当社はパイプラインを築き上げ、重篤で治療が困難なアルツハイマー病、脊髄性筋萎縮症、筋萎縮性側索硬化症(ALS)のための可能性ある治療法の探索を含む 最先端の研究プログラムを推進しています。 当社は複雑な疾患の根底にある、生物学的なメカニズムの研究に尽力しています。当社は治療オプションが、たとえあるとしても非常に少ない疾患に重点を置いています。私達の成功は、常に次のシンプルな質問への回答によって評価されます。 【患者の方々の生活に真の違いをもたらしたか?】

    Job Description

    The position of Associate Director in Clinical Development will support one or more development programs in Japan. The individual who assumes this position will function as a scientific and clinical development lead in areas of strategic interest to Biogen Japan’s development pipeline. The individual will interact with multiple levels of management within Biogen, external stakeholders in the medical community, along with global regulatory authorities to provide strategic leadership for Japan clinical development planning/execution based on in-depth knowledge of therapeutic areas and extensive experiences in clinical development. The candidate should be a driven and innovative builder who has strategic mindset in the therapeutic area and implemented those well.

    Job Responsibilities
    • Medical and/or scientific lead for Japan local studies; for global studies, provide medical/scientific support to headquarter study medical director to ensure appropriate incorporation of Japan specific elements (e.g. unique therapeutic area element, biomarker development) into study design and implementation. Thus has direct responsibility for advancing high priority clinical programs through clinical study design and execution, as well as interpretation of data from key clinical studies.
    • Work closely with Japan/global study team to provide strategic support for clinical operation; Support study site visits and responsible for discussion/education on scientific and medical matters with investigators/site staff
    • Contribute to Japan regulatory strategy discussion, lead medical and scientific discussion from Biogen Japan with Japanese regulatory agency (PMDA)
    • Be the Japan clinical development/scientific lead for registration filings in Japan
    • Clinical Development Plan (CDP): accountable for Japan clinical development strategy
    o Work closely with Japan program management team to integrate the scientific rationale, regulatory requirements, operational feasibility, product development plan, and commercial goals to build a solid strategic framework for the Japanese components of the CDP.
    o Lead clinical development strategy discussion
    o Ensure that each program’s Japanese strategic plan is fully aligned with the global strategy and is fully understood by the Programs team
    • Continue to expand therapeutic knowledge in relevant areas, attend major scientific conferences to establish and maintain scientific collaboration with Japanese KOL physicians with consensus and alignments with global team and Japan
    • Develop and maintain collaboration with program counterparts within R&D and Japan Medical and business unit teams
    • Report to the Head of Japan clinical development and provide support to ensure overall alignment in Japan R&D strategy
    • Contribute to the development of strategic initiatives, specific Business Development activities and overall medical lead for various organizational initiatives in Japan R&D
    • Contribute to overall development of Biogen Japan, support engagement with external steak holders/collaborators including government agencies, pharma-biotech industry groups, academic/physician association, and patient advocacy groups.

    Expires on 14 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    Experience
    • Clinical development experience within in biopharmaceutical industry (at least 3 years in product development), focusing in neurology therapeutic areas (e.g Neurodegenerative diseases such as Dementia/Alzheimers, ALS, Stroke, etc)
    • Experience working with regulatory agencies (PMDA experience preferred)
    • Ability to lead scientific discussion on mechanisms of new research approaches, clinical endpoints, protocol design, or data interpretation
    • Established or has ability to establish peer level relationships with therapeutic area opinion leaders worldwide
    11/26/18
    • Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment
    • Demonstrated strategic and critical thinking
    • Excellent communication skills (oral and written) and excellent organizational skills
    • Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills
    Educations
    • MD, MD/PhD or PhD または同等の知識をお持ちの方
    • Specifically strong clinical credentials and/or drug development experiences in the therapeutic areas combined with strong grounding in scientific research 

  • 20 Dec 2018

    MS Medical Manager (For TECFIDERA)

    Japan

    Permanent Position
    「深く思いやり、人生を変える」という当社のコミットメントを実現するために、国内に必要な機能を持つ組織を築きあげ、当社の革新的な医薬品を日本の患者さんに確実に提供することに注力しています 。 神経疾患、自己免疫疾患、希少疾患の治療法開発に重点を置く、世界屈指のバイオテクノロジー会社です。1978年に設立され、生物学的および低分子薬の発見における当社の研究が、世界で最も広範な多発性硬化症治療法のポートフォリオと、血友病患者さんのための革新的な新しい治療法へと導きました。革新における経験、能力、熱意によって、当社はパイプラインを築き上げ、重篤で治療が困難なアルツハイマー病、脊髄性筋萎縮症、筋萎縮性側索硬化症(ALS)のための可能性ある治療法の探索を含む 最先端の研究プログラムを推進しています。 当社は複雑な疾患の根底にある、生物学的なメカニズムの研究に尽力しています。当社は治療オプションが、たとえあるとしても非常に少ない疾患に重点を置いています。私達の成功は、常に次のシンプルな質問への回答によって評価されます。 【患者の方々の生活に真の違いをもたらしたか?】

    Job Description

    ”Medical Manager provides Scientific and Educational Medical support in a therapeutic area of Neurology to affiliate functions in relation to disease areas and Biogen products
    Medical Manager plans and execute Medical Strategy and Tactics to show the strong leadership as appropriate.
    Medical Manager supports the Head of MS Medical by conducting office based Medical activities.

    ”1. Medical Strategy and Tactics 
    Planning and execution of Medical strategy and Tactics based on Global strategy, customer insight and unmet medical needs
    Collaboration with internal (MKT, R&D at al ) and external stakeholders

    ”2. Medical Information
    Support preparing managing and providing medical information in a therapeutic area of Neurology Including FAQs, Call center support, medical material, review for promotional material and medical training for commercial team et al.

    ”3. Medical Communication and Exchange 
    Establish and maintain contact with Key Medical Experts(KMEs)
    Planning and execution of Advisory board and medical seminar

    ”4. Data generation & publication
    Planning and execution of congress publication and manuscripts about epidemiology and treatment in the therapeutic area of Neurology and our Product
    Collaborative study, Post-marketing study

    ”5. Support life cycle management/ regulatory strategies 
    Leverage (unmet) medical needs in order to support additional lifecycle opportunities based on patient needs on a rolling basis through the development cycle

    Expires on 14 Apr 2019

    Posted By

    Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書(英語版、日本語版でも可)を 表記のメールアドレスまでご送付いただけますとスムーズです。)

    Tel: 080-1118-4497

    nagai.m@peoplesearch.jobs

    Requirements

    【必須(MUST)】

    ”Bachelor’s Degree in science and technology
    Medical Manager (MM) Multiple Sclerosis (CNS, Neurology)/メディカル マネージャー 多発性硬化症(CNS, 神経内科)


    ”製薬でメディカル部門での経験がある(3年以上):Min 3+ years’ experience from the perspective of Medical Affairs (pharmaceutical industry or CRO) 
    製薬でスペシャリティー領域にて、大学病院担当MRやMKTにて、KME(Key Medical Expert)と科学的なコミュニケーションの経験がある:Experience of having scientific and medical communication with KMEs in the pharmaceutical industry ( MR covered University hospital, MKT in neurology, immunology and Hematology) 
    CROや製薬にて臨床研究の企画・実施の経験がある。: Experience of clinical studies
    製薬で本社勤務経験がある。:Experience of working at headquarters of pharmaceutical company
    戦略的な思考、logical thinking, 分析力の高い方:have high strategic thought logical thinking and analytical ability 
    理工系の学部卒以上/MBAがあれば望ましい:Bachelor’s Degree in science and technology / MBA(if possible)
    ビジネスマインドのある方 :have a business mindset
    High-integrity person

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