求人詳細
| 非公開求人 兵庫県 MD-429 |
|
2026.10.15 更新
<NEW>
|
|---|
|
ノンラインマネージャー or スタッフ/医薬開発本部臨床薬理部
大手外資系製薬メーカーでの就業です。(転職:医師求人)
|
| 勤務内容 2026.10.15更新 | |
| 募集科目 |
一般内科、小児科
|
|---|---|
| 日勤の仕事 |
|
| オンコール | なし |
| 備考 | 対象科目:内科、小児科、アレルギー科、免疫科 Minimum Education/Degree Requirements Master's degree (or equivalent) in Medicine, Pharmaceutics, CP or equivalent area of focus with preferably 5-6 years of relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position. Doctoral degree (MD or PhD) in Medicine, Pharmaceutics or CP. Prior CP experience (around 2-3 years) in the pharmaceutical industry, regulatory agencies, or academia preferred. Required Capabilities (Skills, Experience, Competencies) Language skills: English: fluent (Read/Write/Speak). Mindful of local, global, internal, and external cultures to ensure that messages are received positively and effectively. Evidence of strong teamwork, also in global and remote context. Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., CROs, experts, management). Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on TMCP issues. Ability to lead and facilitate meetings. Ability to develop and deliver training related to TMCP topics required. Experience working in the matrix, act in matrix leadership. Very good knowledge in PK and PK/PD, Clinical Pharmacology, biopharmaceutics, clinical drug development and relevant regulatory guidelines. Good understanding of pharmacometric tools (modeling and simulation), their opportunities and limitations as well as basic understanding of statistical principles especially with respect to Clin Pharm trial data. Basic purpose of the job Senior CPhL-Asia supports the clinical development in Asia of new drugs and further development of approved drugs with emphasis on the design and execution of the Clinical Pharmacology (CP)development strategy. CPhL-Asia is accountable and responsible for communicating with regulatory authorities on CP topics and for CP aspects of drug submission in Asia (e.g., submission summaries). CPhL-Asia may act as trial clinical Pharmacologist (TCP; see TCP job profile) for clinical studies in their own project or outside of their own projects. CPhL-Asia may serve as Clin Pharm representative within various teams in Asia (Japan/China) in support of early integration of Japan/China into global development program. Post PoCP, they may serve as CP and TMCP representative in various Asian teams until submission and launch. CPhL-Asia will also serve as main TMCP representatives in all PMO projects in Asia. Accountabilities Ensure timely delivery of state-of-the-art Clinical Pharmacology scientific concepts for decision making throughout clinical drug development and registration in Asia including all necessary processes and documentation. Ensures timely delivery of state-of-the-art Clinical Pharmacology strategy development and implementation. Senior CPhL-Asia is responsible for defining the CP strategy (for instance, defining the drug-drug interaction liability or formulation development strategy for modified release) of assigned project. CPhL-Asia is also responsible for refining the CP strategy in a timely manner as new data become available during drug development. As part of the strategy, CPhL-Asia may define CP aspects in a clin trial protocol and for an eventual submission and further phase IV activities. Senior CPhL-Asia contributes to the Clin Pharm section of official documents (e.g., Information Brochure (IB), label); CPhL-Asia engages with regulatory agencies on matters pertaining to CP during drug development and are responsible for supporting Asian submission and post-submission activities with Clin Pharm and Biopharm expertise. Clinical development project representative Act as Clin Pharm representative in trial and project teams and regulatory meetings. CPhL-Asia serves as Clin Pharm representative within various teams in support of early integration of Japan/China into global development program. Post PoCP, they may serve as CP and TMCP representative in various Asian teams until submission and launch. CPhL-Asia may also serve as main TMCP representatives in all PMO projects in Asia. When delegating a trial to TCP, a CPhL-Asia is expected to ensure that adequate amount of information on the project and trial are provided to the TCP. For instance, a CPhL-Asia is expected to discuss study design and project standards with the TCP. A CPhL-Asia may function as a TCP in certain studies or projects. Driving science and innovation CPhL-Asia leads clinical development trial and project overarching topics from TMCP (e.g. by focus group). CPhL-Asia represents Clinical Pharmacology or TMCP in internal and external initiatives/working groups. CPhL-Asia continuously scouts, evaluates (incl piloting) and implements new methods and strategies in the area of Clinical Pharmacology. Strategic partnerships: CPhL-Asia implements collaborations and strategic partnerships with external bodies. They organize and manage projects with external organizations (e.g. CROs, ARO). CPhL-Asia may serve as subject matter expert (CP, Biopharm) in in –or outlicensing activities Functional processes: CPhL-Asia continuously develops and refines further functional processes and infrastructure. CPhL-Asia is CP (CP and Biopharm) experts and may offer this expertise to other interface functions (e.g, Toxicology, Pharmacovigilance, Customer Information, Marketing, Regulatory Affairs) or to support internal or external working groups. CPhL-Asia presents results internally and externally as well as contributes to scientific publications. Compliance (incl GCP): CPhL-Asia follows all ICH GCP, other relevant authority regulations and internal guidance to protect the rights, safety and wellbeing of trial subjects, including sample chain of custody, data privacy and data integrity. In addition, obligations outside the field of clinical studies, such as EHS, Pharmacovigilance, anti-corruption, BI-internal guidance should be followed. ※記載の件数等は目安の数字です |
| 求人の特徴 |
勤務条件 原則オンコール呼び出しなし、土・日・祝休み、当直なし |
| 勤務日時 2026.10.15更新 | |
| 勤務日 |
|
|---|---|
|
|
| 勤務時間 |
|
|
|
| 休憩時間 |
45分
(概ね 12:00〜12:45)
|
| 勤務条件 2026.10.15更新 | |
| 給与 |
|
|---|---|
| 制度その他 | 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 |
| 契約期間 |
契約期間の定め
なし
|
| 契約更新 |
更新
なし
|
| 試用期間 |
試用期間の定め
あり
|
|
試用期間
勤務開始日から3ヶ月
|
|
|
試用期間中の労働条件変更
なし
|
|
| 勤務開始時期 | 応相談 |
| 退職に関する事項 |
定年制
あり
|
|
定年
60歳
|
|
|
継続雇用制度
あり
|
|
|
自己都合退職に関する手続き
就業規則による。退職は1ヶ月前までに申し出ること。
|
|
|
解雇の事由および手続き
就業規則による。
|
|
| 受動喫煙対策 |
対策
あり
|
|
施設内における全面禁煙の実施
あり
|
|
|
喫煙室の設置
なし
|
|
| 勤務場所 2026.10.15更新 | ||
| 所在 |
|
|
|---|---|---|
| 施設 |
|
|
| 募集要項 2026.10.15更新 | |
| 選考方法 | 面接あり |
|---|---|
| 提出書類 |
|
| 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-corp.jp/ |
この医療機関が募集しているその他の求人
- ●常勤
- 一般内科、一般外科/週5日(当直:月0回)/1,000~1,500万円
- 一般内科、一般外科/週5日(当直:月0回)/1,100~1,240万円
- 一般内科、一般外科/週5日(当直:月0回)/818~1,455万円
- 形成外科、皮膚科、眼科/週5日(当直:月0回)/1,000~1,400万円
- 一般内科、脳神経内科、脳神経外科/週5日(当直:月0回)/1,000~1,400万円
- 一般内科、小児科/週5日(当直:月0回)/1,000~1,400万円
- 一般内科、小児科/週5日(当直:月0回)/1,000~1,100万円
- 一般内科、小児科/週5日(当直:月0回)/1,000~1,100万円
- 一般内科、呼吸器内科/週5日(当直:月0回)/1,000~1,350万円
- 一般内科、一般外科/週5日(当直:月0回)/1,000~2,000万円
- 科目不問/週5日(当直:月0回)/1,000~2,000万円
- 科目不問/週5日(当直:月0回)/800~1,050万円
- 科目不問/週5日(当直:月0回)/800~1,050万円
- 一般内科/週4~5日/1,000万円
- 一般内科/週5日/1,000万円~
- 一般内科/週5日(当直:月0回)/1,500万円~
- 皮膚科/週5日(当直:月0回)/1,000万円~
- 一般内科、皮膚科/週5日~(当直:月0回)/1,000万円~
- 眼科/週5日/1,000万円~
- 一般内科/週5日(当直:月0回)/1,000~1,150万円