Description
Associate Director - Site Partnerships & Monitoring Excellence
We are seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren’t afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This is a permanent full‑time position. The role is hybrid and requires that you be on‑site one day per quarter at the Bourne office in London, UK. Approximately 15‑20% travel is required.
Employees enjoy a balance between professional and personal lives. Our hybrid approach empowers you to choose when you work from home or in the office.
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 also ensures cross‑functional and cross‑regional alignment, maintains key site relationships, manages agreements (CDAs/MSAs), oversees budgets, and guarantees operational consistency across Medical and Development organizations.
Roles and Responsibilities
- Supports the oversight and execution of support function strategies in alignment with Astellas and industry standards. This includes communication, coordination, and leadership of key business stakeholders (study teams, global medical leads, focus area leaders) to build relationships and facilitate timely completion of program goals.
- Assists in the development and management of budgets, timelines, relationships, and resources within assigned support functions.
- Contributes to external interactions with industry leaders, investigative sites, experts for advisory board meetings, site visits, interactions, and congresses.
- Supports investigative site relationship management and operating procedures, internal business procedures (SOPs, Global Regulations, Ethics & Compliance, Outsourcing) to ensure adherence to quality standards.
- Strategic Leadership & Operating Model Development: Supports the development, implementation, and oversight of processes and regional infrastructure needed to build the first Astellas global site network and engagement strategy across the late‑stage portfolio, focused on priority countries.
- Leads or collaborates closely with stakeholders to develop and operationalize global study start‑up, feasibility/site selection, and site management for all late‑stage clinical trials in partnership with Clinical Operations.
- Directly manages sub‑functions relevant to the role’s remit.
- May oversee or provide functional leadership and/or manage employees globally (NA, EU, APAC).
- Contributes to cross‑functional process improvement initiatives and change‑management activities within GSMM and the wider COQSCD organization.
- Supports recruitment, training, development, and retention of staff in line with Astellas policies and procedures.
- Participates as a contributing member of internal and external governance committees and panels, including advisory board meetings and congresses.
- Supports site‑ and patient‑centric initiatives, including patient recruitment and retention activities.
- Prepares and manages functional budgets and resources, overseeing investigative site relationships and institutional policies/procedures.
- Works across both early and late‑stage Clinical Operations to develop and manage the site network across the entire M&D portfolio.
- Collaborates closely with M&D Development Heads and Medical Affairs to develop and manage the Site Network and Engagement strategy.
Required Qualifications
- BA/BS degree or equivalent.
- Extensive pharmaceutical drug development experience or experience in clinical trial management or contract research organization – strongly desired.
- Direct line management experience.
- Solid knowledge of clinical trial conduct, including multi‑center, global trials and late‑stage clinical development.
- Experience building relationships with Key Opinion Leaders and investigative research sites across global regions and countries.
- Experience supporting the execution of strategies for project and non‑project support functions.
- Ability to collaborate with cross‑functional and cross‑regional colleagues.
- Experience contributing to global process or system improvement initiatives.
- Strong knowledge of clinical development processes and ICH/GCP.
- Experience building relationships and supporting the management/oversight of external providers (clinical investigative sites, CRAs, functional service providers).
- Strong interpersonal, written, verbal, and computer skills.
- Fluent in English (oral and written).
Preferred Qualifications
- Advanced degree (MS/PhD/PharmD).
Benefits
Global collaboration: Become part of a connected global business of like-minded life science leaders dedicated to improving patients’ lives worldwide.
Real‑world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
Relentless innovation: Shape the future of healthcare.
Culture of growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Legal Notice
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.
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