【募集の背景 / Purpose & Scope 】

This position is accountable for the direct management of assigned monitoring/site management related clinical trial staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

【職務の内容 / Essential Job Responsibilities 】
(雇入れ直後)

Accountable for the identification, onboarding, training and development of monitoring clinical trial talent to support the planning, initiation, execution and close-out of clinical trials with operational excellence.Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.

This position is accountable to the Head, Clinical Site Management Early Development, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of monitoring staff during execution of development trials.

• Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff
• Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports)
• May manage and allocate monitoring resources in more than one region globally
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio
• Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
• Oversee adherence to timelines, standards, processes for work assigned to their staff
• Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff
• Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy.
• Responsible for compliance of direct reports with training and identification and support for any training needs
• Facilitate and support global trial monitoring operational standards and tools
• Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff
• Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports)
• May manage and allocate monitoring resources in more than one region globally
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio
• Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
• Oversee adherence to timelines, standards, processes for work assigned to their staff
• Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff
• Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy.
• Responsible for compliance of direct reports with training and identification and support for any training needs
• Facilitate and support global trial monitoring operational standards and tools
• Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff and rapidly addresses and mitigates potential performance issues
• Collaborates effectively with Portfolio Operations Leads, Clinical Operations Leads and SORD leadership to ensure site monitoring & management staff are delivering as expected and to ensure common framework and standards across clinical programs and trials
• Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for clinical monitoring staff
• May lead process improvements relevant to clinical trial monitoring and site management
• Contribute to development and implementation of best-in-class monitoring/site management standards and processes

(変更の範囲)

会社内での全ての業務

【就業環境に関する要件 / Specific Physical or Environmental Requirements 】

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

【応募要件 / Qualifications 】
<必須 / Required >

Required Qualifications

• BA/BS degree with at least 10 years of executing global drug development programs and trials
• Minimum of 7 years site monitoring and direct people management experience
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operationsand cross-functionally to deliver on portfolio deliverables and objectives
• Must have extensive expertise in risk-based monitoring strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
• Must have experience working across multiple phases of development and in multiple therapeutic areas
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives
• Must have a strong knowledge of clinical development processes and conducting global clinical programs
• Must have proven leadership skills and effective written and verbal communication skills
• Fluent in English.Depending on hiring region, may also be required to be fluent in local language.
• Moderate (~30%) travel required

<歓迎 / Preferred >

• Advanced Degree

【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 → 2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 → Second 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)

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-

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."