Digital Health Solutions Lead

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing 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 caregivers, 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.

This is a technical leadership position, accountable for the definition, oversight, and operational execution of Data Management (DM) deliverables for the Quantitative Sciences and Evidence Generation (QSEG) eCOA/eSource Team. This may include clinical study and program level deliverables for eCOA, and for eSource capabilities, such as wearables, Electronic Health Records (EHRs), applications (apps), eConsent, etc.

In this role, you will be responsible to provide operational leadership for eCOA and eSource deliverables, and to lead process oversight for clinical study and program level implementation. This includes responsibility for project management and technical leadership for the end‑to‑end study phases of setup, conduct, and closeout. This role drives operational excellence, global regulatory compliance, training and technology vendor process oversight for all DHT study level solutions and activities.

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.

• Execution of eCOA and eSource process capabilities at a study, program, and enterprise level. This may include oversight and process ownership for the following: vendor deliverables and timelines, defining data collection, reporting and mapping requirements, establishing study level dataflow, technology/app and device deployment, testing, dataflow and data change oversight and archival activities.
• Establish process for cross‑functional coordination for eCOA/eSource implementation in collaboration with study teams, eCOA/eSource service provider(s), translations providers, and COA Specialist.
• Organize eCOA/eSource related meetings with vendors and study teams in accordance with Astellas processes.
• Oversight of risk assessments and mitigation strategies to ensure on‑time delivery of eCOA and eSource capabilities.
• Provide operational process oversight for eCOA/eSource vendors (Has a broad understanding of how source data come together, and/or how system vendors and solutions function to support the execution of the study).
• Have a comprehensive understanding and application of eSource principles and regulations and represents data standards, quality, and inspection readiness interests with key stakeholders and study teams.
• Ensure adherence with best practices,…