求人名 Director, Clinical Pharmacology
勤務地 Nihonbashi, Tokyo
事業部 オンコロジー開発
雇用形態 正社員
仕事内容
【募集の背景 / Purpose & Scope】
• Have ultimate responsibility and accountability for clinical pharmacology from first-in human through approval, including post-marketing activities for assigned projects
• Therapeutic optimization and individualization (right dose for right patient) by applying state-of-the-art scientific principles and quantitative framework (e.g. MIDD) to evaluate exposure-response relationships based on knowledge of drug disposition, pharmacology, disease biology, patient population, competitive landscape, background therapy, patient variability in PK and responses, formulation effects, impact of immunogenicity
【職務の内容 / Essential Job Responsibilities】
（Immediately after hiring）
• Representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing
• Leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals
• Providing effective oversight of clinical pharmacology aspects of clinical trials (including study design, interpretation and communication of results)
• Participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members
• Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
• Developing 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 and external meetings. For example: meetings with health authorities, congresses, investigator meetings
（Scope of change）
All operations within the company
【組織 / Organizational Context】
• Reports to Clinical Pharmacology Senior Director or higher, within Early Development
• May have direct reporting global or regional clinical pharmacologists
• May have functional management of scientists
【応募要件 / Qualifications】
Education
• PhD or PharmD with fellowship in clinical pharmacology
Experience
• At least 7 years post-graduate experience, in pharmaceutical industry.
• Thorough knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidances
• Working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity
• Have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area
• Knowledge of biologics drug development
• Excellent written and oral communication skills and ability to convey complex technical information clearly
• Expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships
• Experience 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
• Ability and confidence to work independently
【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】
（Immediately after hiring）
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 / Scope of change）
会社の定める事業場および自宅
Workplace determined by the company, or your houce
【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】
当人の経歴・技術・技能等を考慮して決定
Will be decided by the candidate's experience, skill and capability.
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
住宅手当、通勤手当 等
Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
管理監督者 8:45～17:45（月～木）、8:45～16:00（金）
Managers and Supervisors 8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
【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-jp.astellas.com/jp/recruit/newgraduates/
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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