Head, Site Management
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
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 Europe or the 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.
