Astellas Pharma Inc.

The purpose of this position is to provide leadership and strategic direction of global site selection, activation, site engagement and recruitment for all development studies as well as the creation, maintenance and execution of global site monitoring and management efforts for late-stage global development trials.

The Head of Site Activation and Late Stage Clinical Site Management will be accountable for overseeing the development and execution of the following activities:

• Establishing new department consisting of Global Study Start Up, Site Engagement and Recruitment, Late Stage Site Management and Study Site Manager Training.
• Global startup and activation of all clinical trials including study planning and milestone management.
• Site Contracting including Site Budgets, Contracts and Payments for all clinical development studies
• Site monitoring and management globally for all late phase trials
• Deployment and oversight of global monitoring standards including risk based approaches (SDV, SDR, Remote Monitoring) applicable across late stage trials
• Develops strategy and site monitoring tools and processes that position Astellas as the partner of choice
• Oversight of development recruitment tactics at study and site level; ensuring diverse patient populations are recruited in applicable clinial studies
• Monitoring related training to support site monitoring & management activities across the early and late stage portfolio
• Site and Sponsor inspection by global Regulatory Agencies in partnership with QA and other functions.
• Utilization of systems that facilitate or drive standard utilization across both early and late stage trials

This position will be responsible for supporting identification and execution of both early and late stage Clinical Operations trial support strategies aimed at increasing productivity and quality while decreasing cycle times and cost and for the development and implementation of cross- functional and cross regional strategies to ensure operational alignment across Medical and Development (M&D).

In addition, this position will be responsible for ensuring that the site monitoring and management delivered across the portfolio upholds quality, is cost effective, and facilitates robust site relationships. 

This position will be a member of the Global Clinical Operations Leadership Team and will provide input into departmental structure, budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.

This position will work closely with leaders across Clinical Operations, Data Science, Regulatory Affairs, the Asset teams, and Clinical Quality Assurance, to ensure strategic oversight and implementation of efficient trial execution. 

Essential Job Responsibilities:    

• Lead the deployment, and optimization of study start up, site recruitment & late stage site monitoring and management organization including standup of monitoring related infrastructure and resources across 15+ regions as a critical enabler of Astellas’ bold ambition to support future state clinical trial execution
• Lead and support all study start up activities leading, site monitoring and management planning activities required to meet FY and multi-year goals. This includes leading Study Start Up and Late Stage Site Monitoring and Management Organization’s annual, midterm, and long-term strategic planning, staffing and budget development processes and activities, as well as the department’s day-to-day budgetary, financial and resource management.
• Lead and manage a large organization that delivers highly complex capabilities to support a cross divisional delivery model across multiple geographic regions
• Lead development and implementation of resource growth strategy to ensure adequate site monitoring and management in expanding study portfolio
• Oversee development, implementation and refinement of monitoring and site management SOPs and standards globally for Astellas globally, across the portfolio; this includes processes and standards to ensure site quality, monitoring oversight, robust site relationships and inspection readiness
• Works across support functions to proactively identify, risk-manage and resolve issues that arise with study teams and within support functions
• Provide direction and oversight for efficient and compliant processes, procedures, and systems to support site monitoring and management strategic planning
• Work with Internal Audit and Quality Assurance stakeholders to define QA/audit needs for site audits globally, provide feedback on the audit approach, track progress/results of Clinical Operations audits and support remediation activities
• Cultivate collaborations and relationships with external organizations to position Astellas as a competitive and responsible world class pharmaceutical company
• Represents Astellas at industry events and brings insights and best practices gained into the company to help shape strategy and further evolve site monitoring and management capabilities

Quantitative Dimensions:

Responsible for an organization of 60+ employees and 25+ contractors globally.

Contribute to overall management of divisional budget as it relates to site management and monitoring budgetary activities

Organizational Context: 

Reports into Head of Clinical Operations & China Development and provides functional leadership and management of ≥ 6 direct reports in the North America, Asia/PAC, and EMEA.

Qualifications: 

    Required

• 20+ years of pharmaceutical industry experience with at least 12 years of direct clinical trial management experience
• Demonstrated experience managing site monitoring and management teams with minimum 10 years in leadership level role
• Demonstrated experience working with clinical trial sites to ensure data quality and inspection readiness.
• Extensive expertise in developing site monitoring and management operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality, and legal aspects)
• Strong Therapeutic area knowledge and the ability to support the design and executive of clinical programs.
• Proven track record of experience working with contract resource organization, functional service providers and third-party vendors
• Proven track record of experience in multiple Therapeutic Areas or disease state/indications including life cycle management
• Recognized leader in standard business procedures and system utilization to support monitoring and site management, and the application of procedures and systems to the business. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of the clinical organization.
• Bachelor’s degree in science or related area of study

    Preferred

•           Advanced degree (E.g., PharmD, PhD)