About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity:
As the Head, Site Management, you will provide leadership and strategic direction in the creation, maintenance and execution of all Early Development global site monitoring and management efforts within Astellas and provide resource management and regional deployment for monitoring and site management within the Early Development portfolio for the execution and compliance of clinical trials.
Within the Early Development portfolio, this position will be responsible for the strategy and execution of resource allocation including regional deployment and utilization of staff augmentation.
Your role reports to the Head of Early Development Clinical Operations.
Key Responsibilities:
- Overseeing the development and execution of the site monitoring and management strategies, as well as site engagement and relationship management across the Early Development portfolio with alignment and partnership with Late-Stage Monitoring.
- Leads development and implementation of resource growth strategy to ensure adequate site management in expanding study portfolio.
- Provides direction and oversight for efficient and compliant processes, procedures, and systems to support site management strategic planning.
- Ensuring that the site monitoring and management delivered across the portfolio upholds quality, is cost-effective, and facilitates robust site relationships.
- Monitoring oversight strategy.
Essential Knowledge & Experience:
- Recognised leader in standard business procedures and system utilization to support monitoring and site management, and the application of procedures and systems to the business.
- Demonstrated extensive leadership experience managing site monitoring and management teams.
- Worked with clinical trial sites to ensure data quality and inspection readiness.
- Proven track record of experience in multiple Therapeutic Areas or disease states/indications including life cycle management.
- 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)
- Proven track record of experience working with contract resource organisations, functional service providers and third-party vendors.
Preferred Experience:
- 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).
- Considered a Subject Matter Expert and a key contributor to initiatives. Leader and a key contributor to initiatives and advancement of the clinical organization.
Education/Qualifications:
- Bachelor’s degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in EU or US.
- This position is 100% home/remote based.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.