Purpose & Scope

The Director, Global Site Management and Monitoring (Late-stage) leads global site management and supports monitoring strategy and execution across Astellas' late-stage Oncology and Biopharma clinical trials.

Reporting to the Head of Global Site Management and Late-stage Monitoring, the role oversees the development and management of a global network of key strategic clinical trial sites, supporting both early- and late-stage clinical operations.

The position provides strategic oversight across clinical program delivery, site monitoring, business operations, vendor and legal management, process and training, operational standards, and site- and patient-centric initiatives. It is also responsible for cross-functional and cross-regional alignment, maintaining key site relationships, managing agreements (CDAs/MSAs), budget oversight, and ensuring operational consistency across Medical and Development organizations.

Role and Responsibilities

• Supports the oversight and execution of relevant support function strategies in alignment with 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 help solve problems, build relationships, and facilitate the timely completion of both drug and non-drug program goals and objectives.
• Assist in the development and management of budgets, timelines, relationships, and resources within assigned support functions, as directed.
• May contribute to external interactions with industry leaders/external industry peers/investigational sites/experts for advisory board meetings, site visits/interactions, and congresses.
• Provide support 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.

• Strategic Leadership & Operating Model Development
• Support the development, implementation and oversight of the processes and regional infrastructure required to build the first Astellas global site network and engagement strategy across the late-stage portfolio, with a focus on defined priority countries.
• Lead and/or collaborate closely with applicable stakeholders to support the development and operationalization of global study start up, feasibility/site selection and site management required to enable successful delivery of all late-stage clinical trials in partnership with Clinical Operations and other key internal stakeholders.
• Direct line management of sub-function(s) relevant to functional remit
• May oversee or provide functional leadership and/or management employees globally (i.e. NA, EU and APAC).
• Considered a valued contributor to department and cross-functional process improvement initiatives, including assisting in change management activities within GSMM and the greater COQSCD organization.
• Supports recruitment, training, development and retention of staff by adherence to Astellas policies and procedures.
• May participate as a contributing member of internal and external governance committees and panels, including those involving relevant service providers, Key Opinion Leader advisory board meetings, and congresses.
• Support the development of Site and Patient centricity initiatives, including patient recruitment and retention activities.
• Supports the preparation and management of functional budgets and resources and oversight of clinical trial investigative site relationships and institutional policies/procedures, and inter-workings.
• Works across both Early and Late-stage Clinical Operations support site network development and management across the entire M&D portfolio.
• Collaborates closes with M&D Development Heads and Medical Affairs to help develop and manage the Site Network and Engagement strategy.

Required Qualifications

• BA/BS degree or equivalent.

• Extensive pharmaceutical drug development, or experience in clinical trial management or contract research organization experience is strongly desired
• Demonstrable direct line management experience.
• Solid knowledge of clinical trial conduct, including multi-center, global trials and late-stage clinical development.
• Experience in working and building relationships with Key Opinion Leaders and Investigative Research Sites across different global regions and countries.
• Experience in supporting the execution of strategies for relevant project and non-project support functions.
• Demonstrated ability to collaborate with cross-functional/cross-regional colleagues.
• Experience contributing to global process or system improvement initiatives.
• Must have a strong knowledge of clinical development processes and ICH/GCP
• Experience in building relationships and supporting the management/oversight of external providers (e.g. clinical investigational sites, contract research organizations, functional service providers and other clinical suppliers)
• Strong interpersonal, written, verbal, and computer skills.
• Fluent in English (oral and written)

Preferred Qualifications

• An advanced degree (MS/PhD/PharmD) is preferred.

Additional Information

• Approximate (15-20%) travel required
• This is a permanent full-time position.

Location and Working Environment

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.

Salary Range

$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

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