Jobs list of Pharmaceutical & Clinical Development
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NEWJob number: JN -012025-182483 Posted: 2025-01-10
メディカルインフォメーション
薬剤師資格もしくは理系修士以上をお持ちの方必見です。5 - 6.5 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is providing a variety of services to pharmaceutical and medical device companies and other healthcare companies.
- Responsibilities
- 学術情報の収集、評価、集積
社内に向けた戦略や資材作成、学術情報提供
外部向け使用スライドの学術的検証
Patrick Chang
Pharma -
NEWJob number: JN -122024-180691 Posted: 2025-01-10
【本郷三丁目】学術（学術情報の収集・提供／学術セミナーの企画・推進など）
臨床の知識・経験のある方必見です!5 - 7 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- 同社は眼鏡・コンタクトレンズケア事業を展開しています。
- Responsibilities
- 医師、視能訓練士等とのコミュニケーションを通じた、学術情報の収集・提供、紐帯強化
学術セミナー・学会展示等の企画・推進
国内外の大学・眼科施設・企業等との学術研究・連携・勉強会等の推進
学術情報の社内共有・営業活動への技術サポート等
週1回程度の国内出張、2～3か月に1回程度の海外出張（主に東南アジア）があります。
Takahisa Hitotsumatsu
Medical Device -
Job number: JN -012025-182487 Posted: 2025-01-08
メディカルインフォメーション
薬剤師資格もしくは理系修士以上をお持ちの方必見です。5 - 6.5 million yen Osaka Pharmaceutical Clinical Development
- Company overview
- Our client is providing a variety of services to pharmaceutical and medical device companies and other healthcare companies.
- Responsibilities
- 学術情報の収集、評価、集積
社内に向けた戦略や資材作成、学術情報提供
外部向け使用スライドの学術的検証
Patrick Chang
Pharma -
Job number: JN -012025-182471 Posted: 2025-01-08
リアルワールドCPM
SSV～COVの戦略立案及び進捗管理の経験をお持ちの方必見です。7.5 - 14 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
- Responsibilities
- 臨床研究・医師主導治験のClinical Lead またはProject Leadとして次のような業務をお任せします。得意業務やキャリアパスに応じて役割を決定します。
【Clinical Lead】倫理指針または臨床研究法下で実施される臨床研究におけるClinical Operationのマネジメント
CRAのリーダーとして、SSV・SIV・症例登録促進・SDV・データクリーニング・COV業務の、1. 戦略策定、2. CRAへの指示、3. 進捗管理、4, リスクマネジメントを担う
【Project Lead】倫理指針または臨床研究法下で実施される臨床研究のプロジェクトマネジメント
バーチャル組織のリーダーとして、試験立案～Publicationまでの、1.タイムライン、2. 予算、4. 人員、4. リスク、を管理する
RFPに対する見積書及び提案書を作成する
Patrick Chang
Pharma -
Job number: JN -072024-146307 Posted: 2024-12-25
【東京】臨床開発プロジェクトマネージャー
臨床開発プロジェクトマネージャー経験者必見です!6 - 9 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- 臨床開発プロジェクトのスケジュール・リソース・コスト管理
社内意思決定プロセス管理
関連部門（臨床開発、薬事、非臨床、CMC等）で構成されるプロジェクトチームのコミュニケーションマネジメント
共同開発先・導出入先との協業プロジェクトのアライアンス業務
歓迎条件:
海外スタッフを含むグローバルチームでの業務経験
上級レベルの英語コミュニケーション能力 （グローバルチーム会議をファシリテートできる会話能力）※海外拠点や海外他社協業先とのグローバルプロジェクトの担当機会あり
抗がん剤領域の新薬開発経験
プロジェクトマネジメント管理ソフトの使用経験（例：MS-Project、Planisware等）
Project Management Professional （PMP）資格
Patrick Chang
Pharma -
Job number: JN -072024-146306 Posted: 2024-12-25
【東京】CTL（クリニカルチームリーダー）
臨床開発のモニタリング経験者必見です!6 - 8 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- 治験実施計画書、同意説明文書及び症例報告書の作成（補助）
モニタリング計画書等、各種手順書の作成
モニタリングおよび施設対応の実施責任者として、モニターを指揮して治験を実施
モニタリング報告書・必須文書・症例報告書等の確認
担当試験に係わるチーム内（モニター）教育
Patrick Chang
Pharma -
Job number: JN -092024-176771 Posted: 2024-12-18
Senior CRA
全力で仕事に取り組む社員／自ら働き方を選べる0 - 0 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a global pharmaceutical company with offices across 81 countries.
- Responsibilities
- Main responsibilities:
For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
Anticipate and identify site issues that could affect timelines and develop alternative solutions.
Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise.
Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements.
Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
Responsible for coaching and mentoring CRAs and providing input into their development.
Responsible for mentoring CRAs for various aspects of work.
May be responsible for being the country point of contact for CROs for an assigned study.
May participate/lead in global/local task forces and initiatives. Responsible for activities as
assigned by manager.If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
If assigned; With guidance, may serve as key point of contact in country/district for assigned study.
Update Impact/Tesla with country-level information: Country-level planning timelines, LSR
assignments, etc.If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives.
Provides feedback on investigators/sites on an on-going basis based on the site performance.
Interacts and builds professional and collaborative relationships with peers and site monitors.
Elaine Montes
Medical Device -
Job number: JN -122024-181072 Posted: 2024-12-16
【東京】臨床試験のデータマネジメント担当（臨床開発）※東証プライム上場／福利厚生◎／在宅一部有
キャリア実現のための成長サポート制度が充実／多様な人財の更なる活躍推進6 - 8.7 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client boasts of its size as a major group, and its business operations are centered on the tobacco, pharmaceutical, and food businesses.
- Responsibilities
- 【キャリア実現のための成長サポート制度が充実／多様な人財の更なる活躍推進】
■業務内容：臨床試験のデータマネジメント業務をお任せします。DM計画書、報告書の作成
CRFの設計
チェック仕様書の作成
EDCシステム、CDMシステムのCSV実施
データクリーニング
コーディング
外部データの管理
・データ固定など
その他、各種標準の管理、業務委託先の管理、適合性調査対応、など
Martin Tsvetkov
Pharma -
Job number: JN -112024-180406 Posted: 2024-12-06
[Tokyo] Clinical development (planning, promotion, management work)
アライアンスマネージメント経験者必見です!6 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- -
- Responsibilities
- 医薬品開発における臨床開発の立案・推進・管理業務※プロジェクトの管理・CROマネージメント・アライアンスマネージメントなどを担っていただく業務です。
Elaine Montes
Medical Device -
Job number: JN -122024-180972 Posted: 2024-12-05
【東京】Clinical Excelienceシニアマネージャー
放射線治療に関する臨床知識をお持ちの方必見です!10 - 15 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client offers medical technology products.
- Responsibilities
- 当ポジションでは、当社のテクニカルサポート部門ならびに、医学物理の分野の検証・コミッショニング（放射線管理）を行う「クリニカルエクセレンス」部門のチームマネジメント、顧客対応、製品導入に対する支援、顧客フィードバックを包括的にマネジメントして頂くことになります。
担当製品については当社で取り扱う製品ならびにソリューション全体になります。
Shotaro Tsubaki
Medical Device -
Job number: JN -072024-143283 Posted: 2024-11-29
[Osaka & Tokyo] Clinical Research Associate (CRA) in Operation
Rewarding Career, Global Development9 - 14 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.
As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine. - Responsibilities
- MANAGE / MONITOR THE PROGRESS OF YOUR TRIAL ON-SITE OR OFF-SITE, AND CONDUCT, RECORD, AND REPORT YOUR TRIAL IN ACCORDANCE WITH CLINICAL TRIAL PROTOCOL, SOPS, ICH / J-GCP, AND OTHER APPLICABLE LAWS AND REGULATIONS. GUARANTEE THAT YOU ARE
RESPONSIBLE FOR CONTRACT NEGOTIATIONS AND CONCLUSIONS WITH MEDICAL INSTITUTIONS
WORK CLOSELY WITH OTHER CLINICAL TEAM MEMBERS TO TIMELY RESOLVE ANY CLINICAL TRIAL ISSUES THAT ARISE
INEXPERIENCED GIVE APPROPRIATE GUIDANCE TO MEMBERS AND CONTRIBUTE TO THEIR GROWTH
Patrick Chang
Pharma -
Job number: JN -112024-180645 Posted: 2024-11-29
医薬品開発における臨床薬理業務
医薬品の研究開発の経験が活かせます。5.59 - 8.91 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
- Responsibilities
- 開発プロジェクトの臨床薬理部門の主担当として、臨床薬理の観点での開発計画を立案する（臨床薬理試験の計画及びデザイン、用法用量提案や試験デザイン検討に用いるファーマコメトリクス解析の計画、血中薬物濃度及び抗薬物抗体の測定）。
各臨床試験における臨床薬理関連データの取得、解析及び結果の考察を行う。
臨床試験、当局相談、承認申請関連の臨床薬理パートの資料を作成する。
海外を含む規制当局対応や導出入活動の対応を行う。
Martin Tsvetkov
Pharma -
Job number: JN -112024-180099 Posted: 2024-11-22
提案書作成業務
バイオテクノロジーを用いた医薬品開発、製造に関する基礎的な理解がある方必見です。6 - 11 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a leading comprehensive glass manufacturer in Japan. Our business extends beyond glass to include electronics, chemicals, and ceramics, resulting in a well-balanced revenue composition that makes us resilient even in economic downturns. We develop and manufacture innovative materials and products across a wide range of fields, leveraging our high technological expertise and research and development achievements. We supply products to various industries such as construction, automotive, electronics, and medical equipment. Furthermore, we are committed to environmental conservation and the development of sustainable technologies, earning us recognition as a socially responsible company.
- Responsibilities
- 世界中のお客様から受領した開発・製造委託の提案書作成依頼（RFP:Request for Proposal)の内容を分析する
主に千葉工場の技術チームなどと綿密に連携し、お客様に提出する提案書の作成を行う
グローバルの価格決定会議に参加し、提案内容の発表を行い、承認を得る
主に千葉工場や、ウェブなどで、お客様との会議に参加し、提案書の説明、協議を行い、提案書の改訂作業を行う
より競争力のある提案書を作成するため、主に千葉工場の技術チームやグローバルのチームと一緒に、改善活動を行う
Martin Tsvetkov
Pharma -
Job number: JN -112024-179804 Posted: 2024-11-21
臨床開発計画の立案を担うクリニカルサイエンスリーダー
製薬メーカー等での臨床開発業務経験が活かせます。11.1 - 12.6 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
- Responsibilities
- Immunology領域における臨床開発計画の立案（後期開発品における市場価値最大化の検討含む）
臨床試験のプロトコルの策定
当局相談資料や申請資料などRegulatory Agenciesとの対応と方針の決定
国内外Key Opinion LeaderおよびRegulatory Agenciesとの折衝
導入候補品の臨床科学的評価
臨床試験の外部への発表に関する業務
Martin Tsvetkov
Pharma -
Job number: JN -112024-179889 Posted: 2024-11-20
メディカルアドバイザー
臨床または研究環境におけるTAの経験、理想的には肝臓病学、心臓病学および腎臓病学をお持ちの方必見です。6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies. - Responsibilities
- 臨床開発フェーズの全プロセスを通じて、担当治療領域における医療／科学的な確固たるガイダンスを提供することで、当社製品のプロファイルを強化
規制／臨床開発チームと協力し、それぞれの製品の日本での申請と登録を確実にサポート（PMDAの問い合わせへの対応準備など、承認までの臨床部分をサポート）
当社のグローバルな開発戦略と一致する形で、日本の臨床開発計画を策定し、当社グローバル医学に認知されるようにする
治療領域における全体像（リソース/予算の観点からの全プロジェクト/試験）に基づき、Nippon Boehringer Ingelheimが開発／データ構築の決定を行うことをサポート
概念実証後および商業化の後期段階における臨床データパッケージ（CDP）への貢献
マーケティングおよびマーケットアクセスと共に、日本特有のニーズに対応するための統合アセットプランおよび詳細な年間コミュニケーションプランを準備し、グローバルIBP（統合ブランドプラン）と一致させる
臨床／前臨床研究、研究者主導の研究およびRWE（リアルワールドエビデンス）研究を通じて外部の専門家との協力により新しい科学的証拠を構築
製品の利益／リスク評価への貢献
MSL（メディカルサイエンスリエゾン）と共に外部専門家からの洞察を得て、医療戦略を提案
Martin Tsvetkov
Pharma -
Job number: JN -112024-179866 Posted: 2024-11-20
メディカルアドバイザー
臨床または研究環境でのTA経験をお持ちの方必見です。6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies. - Responsibilities
- 治療領域（TA）戦略に沿った日本におけるCDMA（臨床開発および医療業務）活動を、前臨床開発の開始から商業化の後期段階まで遂行するために貢献いただきます。
担当領域：心不全・CKD領域
Martin Tsvetkov
Pharma -
Job number: JN -112024-179847 Posted: 2024-11-20
メディカルアドバイザー（肥満症／MASH領域）／ノンラインマネージャー or スタッフ
生命科学における修士号お持ちの方歓迎6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.
Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies. - Responsibilities
- ■業務概要：日本におけるCDMA（臨床開発およびメディカルアフェアーズ）活動を、TA（治療領域）戦略に基づき、前臨床開発の開始から商業化の後期段階まで実行することに貢献いただきます。担当領域：肥満症／MASH領域
■担当業務：当社製品のプロファイルを強化するため、臨床開発フェーズ全体にわたり、グローバルのコーポレートおよび他部門と協力して、担当する治療領域における医学的／科学的な堅実なガイダンスを提供
規制／臨床開発チームと協力して、該当する製品の日本での申請および登録を確保・サポート（PMDAからの照会への対応準備など、承認までの臨床部分をサポート）
同社グローバルメディスンによって認識され、グローバル開発戦略と一致する、日本の臨床開発計画を策定する責任を負う
治療領域における全体像（リソース／予算の観点からのすべてのプロジェクト／試験）に基づいて、同社が開発／データ構築の意思決定を行うのをサポート
概念実証後および商業化の後期段階におけるCDP（Clinical Data Packages）への貢献
マーケティングおよびマーケットアクセスと協力し、日本の特定のニーズに対応するための統合資産計画および詳細な年間コミュニケーション計画を作成し、グローバルIBP（Integrated Brand Plan）と整合させる
臨床／前臨床研究、研究者主導研究およびRWE（Real World Evidence）研究を通じて、外部専門家との協力により新しい科学的証拠を構築
製品の利益／リスク評価への貢献
MSLとともに外部専門家からの見識を得て、医療戦略を提案
Martin Tsvetkov
Pharma -
Job number: JN -112024-179648 Posted: 2024-11-15
薬事コンサル（最先端医療技術のコンサルティング業務）
薬剤師、獣医師の資格をお持ちの方必見です。6 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a provider of medical-related services through the Internet.
- Responsibilities
- AIプログラム医療機器や遺伝子治療など、最先端医療技術の薬事支援コンサルタント業務国内外のベンチャー企業や新規参入を目指す異業種企業が開発する最先端医療技術の社会実装を薬事の面から支援します。薬事戦略や開発ロードマップ、事業化マスタープラン等の策定
規制当局（PMDA及び厚労省）対応、PMDA対面助言等の代行
対面助言資料やオーファン指定申請書など、各種薬事関連書類の作成
AMED等のグラント申請支援
上記に係るコンサルテーション、文書作成（翻訳含む）、プロジェクトマネージメント
Martin Tsvetkov
Pharma -
Job number: JN -072024-143554 Posted: 2024-11-11
Clinical Project Manager / Clinical Leader
Global Trail and high salary8.5 - 17 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
- Responsibilities
- Manage Clinical Trials
Patrick Chang
Pharma -
Job number: JN -082024-173994 Posted: 2024-11-07
Project Manager
社員の成長を大切にする企業／オープンカルチャー10 - 18 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a global pharmaceutical company with offices across 81 countries.
- Responsibilities
- Main responsibilities:
Main activitiesSupporting the growth of team members
Complying with and enforcing industry and company rules
Budget management for assigned projects
Responsibility for conducting evidence meetings in each disease area
ESG budget management
Influence related departments, joint companies, and external stakeholders and build trust
Smoothly carry out assigned tasks such as research with high expertise
Appropriately manage the progress of reexamination applications and submit applications within
the deadline.
Evidence Solution Project DutiesActivities to generate evidence (data) required or needed by patients or medical professionals by conducting tests and investigations,
The main task is project management from the decision to conduct a study to publication.
In general, this is similar to the PMS work under GPSP, but Companys unique feature is that it covers not only GPSP PMS but also studies conducted by Medical Affairs.
Integrated management of evidence generation projects (including publications)
Project Progress/BudgetAll evidence generation projects involving the Medical Headquarters
Act as a liaison between internal and external stakeholders in evidence generation activities
Responsible for creating an environment in which the team can act as a think tank for internal and external regulations related to evidence generation activities, and sharing and thoroughly disseminating information (including education) to necessary internal stakeholders
Manage budgets as project owner
Facilitate cross-sectional projects within the Evidence Solutions Group
Facilitate cross-sectional projects within the Evidence Solutions Group for the therapeutic area in charge
Improve the quality of the team so that the evidence generation department of Company
Medical Headquarters becomes the best model representing the industry
Elaine Montes
Medical Device