Senior Scientist 《PK, clinical pharmacologist》

Job Details

<求人タイトル>

17137 Senior Scientist 《PK, clinical pharmacologist》

<職務内容>

Major Accountabilities (Core Responsibilities)
1. With minimal guidance, represents PK Sciences as a core member of project teams in Japan.
2. Participates or leads PKS sub-team to develop and integrate PKS strategy for compound progression and development.
3. Works with manager to effectively communicate data, strategy and results to the project teams.
4. Aligns plans and strategies with sub-teams, project teams, manager and leadership team.
5. Analyze and interpret PK/TK/PD/IG data generated during discovery, early and/or full development; present results to the program.
6. Works with team under management supervision to identify potential project hurdles.
7. With minimal guidance, contributes to internal transition documents, clinical study protocols, clinical study reports, investigator brochures, CTNs and NDAs within agreed timelines, and meeting all regulatory requirements.
8. May participate in cross-departmental teams, department-wide initiatives and work streams.
9. Completes all required organizational trainings and requirements according to corporate timelines.
10. Adhere in strict accord to the appropriate SOP and GxP guidelines.
11. Ensures adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
12. 100% timely delivery of all training requirements including compliance.
Technical Responsibilities:
・Proficiency with key software (e.g. Phoenix)
・PK/TK study design expertise
・Regulatory knowledge of area of CP & Biopharmaceuticals
・Clinical study design
・Regulatory guidance
・CP strategy, discovery characterization

<応募要件>

Education:
・MSc, PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic background
Languages:
・Fluent Japanese (oral and written)
・Intermediate English (oral and written)
Experience:
・2+ years in the pharmaceutical industry
Professional Requirements:
1. 2 + years of relevant experience in PK Sciences or related research area. Appropriate training may be given.
2. Experience working in a drug discovery or development or relevant experience in a CRO, Pharma or Biotech highly desirable.
3. Knowledge of related disciplines (e.g., biostatistics, toxicology, regulatory) in the drug discovery or development process.
4. Ability to work as part of a cross functional team in a highly dynamic, matrixed, project team environment.
5. Strong organizational and project skills with critical thinking and problem solving skills.
6. Strong oral and written communication skills.

<会社概要>

製薬業界で最も強力なパイプラインを持つ企業の一つとして評価の高い大手外資系製薬会社です。今後も数多くの新製品の上市が予定されています。また、在宅勤務、スーパーフレックス制や高い有給休暇の取得率など、ワークライフバランスを重視した就業環境が魅力的な企業です。

給与:経験・能力による(応相談となります)
就業時間:9:00~17:45 (就業時間 7 時間 45 分)スーパーフレックスタイム制度、在宅勤務制度あり

<注目ポイント>

薬物動態や臨床薬理のご経験を活かしていただくSenior PK Scientistのポジションです!本社との関りも多く、英語力を活かしてグローバルにご活躍いただけます。ご興味がございましたら、是非お気軽にお問い合わせください。

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company