【募集の背景 / Purpose & Scope 】
Provide clinical pharmacology scientific support to individual projects/studies within a therapeutic area.
【職務の内容 / Essential Job Responsibilities 】
(雇入れ直後)
- Providing scientific support on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing
- Participating in cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals.
- Providing clinical pharmacology input to clinical trials (including study design, interpretation and communication of results)
- Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
- Participating in development of high-quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans
- Presentation of clinical pharmacology aspects of the global clinical development program at internal or external meetings.
(変更の範囲)
会社内での全ての業務
【 Quantitative Dimensions 】
- Be involved in the design of at least 2-3 Early Development or Clinical Pharmacology strategies per year.
- Contribute to on an average 1-2 Translational Science Plans on novel projects.
- Be involved in the design of at least 2-3 study protocols per year
- Provide scientific contributions to 1-2 Safe First Dosing documents for compounds proposed to be entered first to humans.
- Contribute to on average at least 1-2 IB/IMPD/IND regulatory documentations.
【応募要件 / Qualifications 】
<必須 / Required >
- PhD or PharmD with fellowship in clinical pharmacology or MS with at least 7 years of industry experience
- 2-4 years post-PhD with thesis relevant to Clinical Pharmacology; or PharmD with clinical pharmacology fellowship and at least 2 years industry experience; or MS with at least 7 years of industry experience within Clinical Pharmacology
- Knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidances
- Working knowledge of biomarkers, bioanalytical methods, immunogenicity
- Excellent written and oral communication skills and ability to convey complex technical information clearly
- Knowledge of clinical pharmacology in drug development, pharmacokinetic/pharmacodynamic relationships with a strong scientific and strategic mindset
- Knowledge of integrating modeling and simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan
- Adaptability and curiosity to learn about new modalities and apply core clinical pharmacology principles to novel therapeutics
- Curiosity and drive to ask questions, learn and keep abreast of literature.
- Confidence and ability to present to and influence senior leaders.
- Ability to critically analyze problems and provide creative/innovative solutions.
【応募書類 / Application Documents 】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed
【選考プロセス / Selection details 】
書類選考 → 1 次面接 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Final interview
- Please be advised that there might be a change in the process.
【勤務地 / Location 】
(雇入れ直後)
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo
(変更の範囲)
会社の定める事業場および自宅
【勤務開始日 / Start Date 】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration 】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period 】
試用期間原則なし
No probation period in principle
【給与 / Salary 】
①基本給:当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合:裁量労働手当として職務グレードに応じて 50,000 ~ 100,000 円支給
③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
① Base salary: will be decided by the candidate's experience, skill and capability.
② When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000 ~ 100,000yen, based on the Grade)
③ When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise 】
有り
【賞与 / Bonus 】
有り
【諸手当 / Allowance 】
裁量労働手当、住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours 】
8:45 ~ 17:45 (月~木)、 8:45 ~ 16:00 (金)
裁量労働制の場合、所定労働時間を働いたものとみなす
8:45 ~ 17:45 ( Mon ~ Thu )、 8:45 ~ 16:00 ( Fri )
Discretionary Work System
【休日 / Holidays 】
完全週休2日制(土曜・日曜)、祝日、 5 月 1 日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave 】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare 】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【アステラス製薬 採用サイト / Career web site 】
https://re-
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."
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