【募集の背景 / Purpose & Scope】

• This position is accountable for the planning, set-up and execution of assigned drug trials 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).
• This position is accountable to the Clinical Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials.
• Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input.
• This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables.
• Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.
• Reports to the Clinical Operations Lead or above. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables and may provide supervision and coaching to supporting Clinical Trial Managers, including contractors.

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

• Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities
• Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
• Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
• Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
• Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team
• Lead feasibility assessment and selection of countries and sites for trial conduct
• Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables
• Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
• Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders
• Participates in inspection readiness activities including coordination of clinical study team deliverables
• Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
• Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy
• Facilitate and manage regional KOL interactions, as applicable
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
• Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
• Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
• Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials

(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 / Must>

• BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
• Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
• Requires proven project management skills and trial leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
• Fluent in English
• Moderate (~25%) 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 → 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

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When 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

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."