Job Advert Title: Site Network Lead APAC
Location: Nihonbashi,Tokyo
Division: Early Development
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
This position is accountable for the strategic development, oversight, and maintaining the network of key strategic clinical investigative site relationships who provide advice and execute work on the Astellas portfolio of clinical studies. The network of key strategic sites support of both early and late-stage Clinical Operations across all focus areas with emphasis on early clinical development.
. Support functions in scope for this position may include:
•Clinical program delivery
•Monitoring
•Business Operations (US, EU, APAC) – includes staff onboarding, department performance management and enhancement, and departmental communication management
•Collaboration with Clinical Science (Medical), Portfolio Leadership (Focus area leadership and Asset Leads), Medical Affairs, Translational Medicine, and Clinical Pharmacology Early Development
•Legal Operations Vendor Strategy & Management
•Process, Training & Development
•Study Operations Standards - includes the overall study operational and support model
They are responsible for input and strategic planning and maintaining relationships with key strategic global clinical trial centers who will provide consultancy advice and input as well as execute Astellas clinical development programs.
This position may also support development of Confidentiality Disclosure Agreements (CDAs) and Master Clinical Trial Agreements (MCTAs) with these key strategic centers as well as maintain budget control over associated activities and processes necessary to oversee and maintain the site network. This position will be responsible for development and implementation of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development and across the early and late stage (including MA and RX+, where applicable) clinical organizations for the relevant support function.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
•Responsible for the oversight and execution of relevant support function strategies against established Astellas and industry standards. This includes effective communication, coordination and leadership of key business stakeholders (e.g. study teams, global medical leads, and focus area leaders) / functions to solve problems, build relationships, develop contingency plans to support timely completion of both drug and non-drug program goals and objectives.
•Responsible and accountable for the development and management of budgets, timelines, relationships, and resources within assigned support functions
•May participate in external interactions with industry leaders/external industry peers/investigational sites/experts for advisory board meetings, site visits/interactions, and congresses
•Recognized leader in investigative site relationship management and operating procedures, internal business procedures (SOPs, Global Regulations, Ethics & Compliance, Outsourcing) and the application of procedures to the business to ensure adherence to quality standards for assigned support function
•Considered a Subject Matter Expert and key contributor/leader in department and cross-functional process improvements / initiatives, includes serving as the change management champion/lead within Early Clinical Operations
•May participate as a member of internal and external governance committees and panels, including: relevant service providers, Key Opinion Leader advisory board meetings, and congresses
（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.
•This is a hybrid position (two days on-site) based in Tokyo, Japan that supports a global team. Joining early morning and/or late evening teleconferences is sometimes required.
【応募要件 / Qualifications】
＜必須 / Required＞
•BA/BS degree with ≥8 years of experience (or 6 years direct experience with an advanced degree (MS/PhD/PharmD) in pharmaceutical drug development, direct clinical trial management experience or contract research organization experience is strongly desired;
•Must have strong knowledge of clinical trial conduct, including, multi-center, global trials and early stage clinical development.
•Experience in working and building relationships with Key Opinion Leaders and Investigative Research Sites
•Demonstrated leadership skills and ability to effectively collaborate with cross-functional/cross-regional colleagues
•Must have a strong knowledge of clinical development processes and ICH/GCP
•Experience in building relationships and management/oversight of external providers (e.g., clinical investigational sites, contract research organizations, functional service providers and other clinical suppliers)
•Must have excellent interpersonal, written, verbal, and computer skills.
•Fluent in English (oral and written)
•Approximate (20-25%) travel required
＜歓迎 / Preferred＞
•Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant project and non-project support functions.
•Demonstrated ability to successfully lead global process or system improvement initiatives
•Advanced degree (e.g., Masters, PharmD, PhD)
【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 → 2nd 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）、専門業務型 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-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."