Head, Clinical Data Enablement, Data Aggregation

Head, Clinical Data Enablement, Data Aggregation

About Astellas

At Astellas, experience is coupled energised with a relentless challenger spirit.
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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

The Opportunity

The Clinical Data Enablement (CDE) Head of Data Aggregation 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 are able to be shared to internal Astellas consumers following an established dataflow. Data review and data cleaning are outside the scope of this role.
As 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 precursor to submitting data to regulatory bodies and/or providing responses to regulatory questions.
This role reports to Head, Clinical Data Enablement, Data Science Clinical Data & Information Strategy.

Hybrid Working

This position is based in the UK or Republic of Ireland. At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver. Candidates interested in remote work are encouraged to apply.

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 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 UK or 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.