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Astellas Pharma Director Data Management Programming in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

  • The Director, Data Management Programming leads the EDC, Medical Coding and Data Visualization programming teams and coordinates programming solutions globally for Data Management. The team develops, manages and supports the programming for data management (and related) systems (e.g., data review, CTMS, reports) used to collect, review and clean data in Astellas’s phase I-IV clinical trials globally. This includes the participation in improvement efforts for data management solutions and/or interfaces between data management systems and other applications, as well as the evaluation of new applications and processes. The Director may also oversee the standards, handling, and management of all external sources of data being managed by the Astellas DM organization. This includes, but is not limited to: central labs, imaging data, biomarkers, eCOA, and PK data. The respective role of the Director (i.e., DB build and DM Reports or External Data handling) is determined by business need.

  • The Director, Data Management Programming plays a visible leadership role in defining and assuring compliance with an integrated set of data standards, processes and tools for the design, execution and reporting of clinical trials in Development. The Director, Data Management Programming has functional management responsibility for approximately 5-8 programmers and leads the clinical database build and DM reports aspects or external data handling and management activities for the Data Management function. The Director has global direct reports and is expected to manage all staff members in accordance with local HR and country legal requirements. The Director, Data Management Programming ensures alignment to program level submission plans and acts as the DM Solutions lead in cross-functional project review meetings for their respective area of responsibility.

  • The Director is responsible for the optimal development, allocation and management of Data Management resources to support the global drug development portfolio. This includes vendor oversight, quality management and project management of all EDC, Medical Coding, and Visualization vendors. This role collaborates globally to build an aligned global vendor resourcing strategy for Data Management, as project needs dictate.

  • The Director is a seasoned cross-functional leader in the DM discipline and aligns assigned DM team members to the overall Development mission, goals and objectives. In addition, this role is actively engaged in external industry activities, focused on bringing industry level best DM practices into the Astellas programming and overall DM team.

Essential Job Responsibilities:

  • Functional management of a group of approximately 5 – 8 DM programmers (individual contributors) within Data Management. These programmers may fulfill several roles or systems needs (e.g., EDC, Medical Coding, Visualization, external data, etc.).

  • Responsible for attracting and retaining best in class database programming expertise. Collaborates with HR and DM Head to develop new HR recruitment strategies.

  • Oversight for delivery and quality of all studies with multiple DM vendors. Participates in the selection, oversight and governance of any vendors providing programming support. Collaborates cross functionally to ensure that any issues with delivery or quality are addressed as appropriate.

  • Ensures all EDC, Medical Coding and Visualization programming team members are overseeing vendors to both performance and quality expectations.

  • As a member of the DM Management team, provide input into the annual audit plan and establish and follow up on Corrective and Preventive Actions in response to audit reports issued by Clinical and Research Quality Assurance. May be responsible for leading specific CAPA plans and action items.

  • Strategic thinker and problem solver, who recognizes, anticipates and solves problems; helps individuals to develop problem solving skills. Must be able to delve into high degree of detail, when necessary, across all aspects of DM.

  • Inspires individuals while holding them accountable for project and study delivery and provides expert data management knowledge and input into development programs. Gives team members the autonomy to get the work done, while being able to dive into great detail to assist an individual or team who needs it.

  • Delegates some aspects of work to more senior team members to encourage their growth and development.

  • Strong cross-functional understanding of all processes of data management, statistical programming, biostatistics and clinical, with master level expertise in the DM discipline. Advocates ICH GCP DM requirements to study team members, cross functional management peers and to external CRO partners to ensure on-going focus on compliance.

  • Reviews critical documents and work processes to ensure that they are fit for purpose.

  • Supports process improvement initiatives and develops a culture of continuous improvement to demonstrate improvements in time, quality and costs.

  • Recognized subject matter expert, with ability to influence and lead discussions around data collection, cleaning and reporting requirements. Advocates and supports the connection between data standards and data systems needs.

  • Represents EDC, Medical Coding and Visualization programming discipline to support regulatory inspections and responses to regulatory requests. Ensures on-going communication between QA and respective DM team(s).

  • Serves as decision maker for, and oversees implementation of, new ideas regarding managing data, reports, and processes to improve efficiency, quality, and cost-effectiveness. Ensures alignment in work processes across DM globally.

  • Leads global process improvement initiatives for DM.

  • Responsible for development, approval and implementation of best-in-class processes and standard operating procedures (SOPs) for DM.

Quantitative Dimensions:

  • The Director, Data Management Programming has full accountability for delivery on all drug development programs within the area of responsibility. This includes all phases of development, including post-marketing support.

  • Develops and implements 1-3 year Data Management specific objectives and plans. Understands the contribution to broader Data Management, Data Science and Development plans and ensures alignment with these plans.

  • Participates in development of 3-5 year Data Management vision, mission, objectives and plans. May take leadership for delivery of specific actions and goals from long term strategic plan.

  • This role contributes to annual resource and budget planning activities from a DM perspective and is the key Database Programming lead in DM outsourcing efforts.

  • The Director has accountability for up to 8 external vendors and for up to 10 systems to support data collection, review and cleaning.

  • Oversees and manages DS budget expenditures for direct reports.

  • The Director participates in external industry level activities and may represent Astellas in industry publications or presentations.

Organizational Context:

  • Reports to the Senior Director, DM Solutions.

  • Functional management of a global team of approximately 5 – 8 programmers with responsibilities for global projects, local projects and individual clinical studies.

  • May manage lower-level DM Line managers, depending on the overall size of team, and scope of responsibility.

  • Member of Data Management management team. Peers with other DM line managers (6-8) and DS functional level managers with similar people management responsibilities.

Qualifications:

Required

  • BS or MS degree in Computer Science, Informatics, or life science discipline; minimum of 12 – 15 years in pharma or CRO industry, with 10 years in functional/line or project management role.

  • At least 8 years’ experience in working on global clinical studies and projects or global process and system initiatives, with a minimum of 5 years’ experience in a database programming or related role.

  • Industry expertise with the ability to recognize implications of new directions, trends, and developments in the area of data capture and data management applications within the pharmaceutical industry.

  • Mastery level subject matter expertise in all aspects of the Data Management (DM) discipline. Application of all end-to-end activities involved in clinical data management to support a drug development program. Has a big picture understanding of how the data come together to support the submission strategy for multiple compounds. Represents DM and Data Science in cross functional meetings and discussions.

  • Knowledge of systems outside of data management, such as safety systems, Clinical Trial Management Systems, and also electronic patient reported outcome tools. Experience and expertise in using one of the programming languagues SAS, ORACLE and SQL is preferred.

  • Global submissions experience.

  • Demonstrated ability to influence stakeholders and negotiate mutual wins.

  • Outstanding verbal and written communication skills. Ability to lead across geographies and cultures.

  • Very good understanding of all phases of clinical development, and processes in data science.

  • Experience in all aspects of clinical trials for data management, and in working as a member of a project team including design of clinical studies and review of clinical study protocols.

  • Strong knowledge of data standards in industry (CDISC, CDASH).

  • Good understanding of the various functions and expert groups contributing to Drug Development .

  • Demonstrated ability to translate strategic plan for Development, Data Science and Data Management into goals and objectives for direct reports.

  • Demonstrated leadership skills and ability to effectively prioritize own group’s activities for development projects and clinical trials.

  • Demonstrated ability and experience in leading global process or system improvement projects.

Preferred

  • SCDM Certified Clinical Data Manager (CCDM) preferred.

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

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Category Data Science

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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