DescriptionHead, Clinical Data Enablement, Data AggregationAbout 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 Clinical Data Enablement (CDE) Head of Data Aggregation, you will lead a globally distributed team focused on establishing the data flow from source vendors to Astellas for Phase I-IV clinical trials executed by Astellas. This includes transforming data for data review and cleaning purposes while also ensuring that these data can be shared with internal Astellas consumers following an established data flow. Data review and data cleaning are outside the scope of this role. As a Head of Data Aggregation, you will play a key role in ensuring that the clinical results data collected in Astellas clinical trials are available for data cleaning and review which is a precursor to submitting data to regulatory bodies and/or responding to regulatory questions. Key Responsibilities:
Acting as the primary contact and subject matter expert for the Data Aggregation team responsible for resource planning, workload assignment (allocation and prioritization), issue resolution, and related escalations to the Data Science Lead Team (DS LT). Defining and leveraging metrics to enable a culture of continuous learning and improvement to optimize the clinical data flow and the availability of clinical results data for decision-making. Shares these metrics and related innovations with the DS LT and drives strategic initiatives in this area. Leading engagement with vendors providing source data (i.e. vendors providing lab results, ECGs, biomarkers, etc) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately. Contributing to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within the department and across Astellas broadly. Ensuring cross-functional collaboration with areas performing data management, clinical operations, etc. to address any issues with the delivery or stability of the clinical data flow as appropriate.
Essential Knowledge & Experience: Extensive experience in pharma or the CRO industry working on global clinical studies and projects or global process and system initiatives. Effective communication and ability to build strong relationships with vendors and internal stakeholders, lead negotiations to achieve the best outcomes for Astellas for service or data delivery support and issue resolution. Significant experience working on systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning. Demonstrable leadership and collaboration across geographies and cultures. Solid understanding of all phases of clinical development. Preferred Experience: Prior experience with people management responsibilities. Experience using at least one programming language (i.e. R, Python, SAS, SQL, etc). Demonstrated ability and experience in leading global process or system improvement projects. Knowledge of data standards in industry (CDISC, CDASH). Education/Qualifications: BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline or equivalent. Additional Information: This is a permanent, full-time position. This position is based in the UK or the Republic of Ireland. 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.
