Site Network Lead APAC

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)