About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're 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.This position is hybrid and will require you to be on-site 1 day per quarter at Bourne office in London, UK. The role is offered on a hybrid basis. Approximate (15-20%) travel required
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to 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 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.
Continue: Role and Responsibilities
- 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
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all 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: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A 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.
Our Organizational Values and Behaviours
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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