Astellas Pharma Director, Clinical Science Operations in Northbrook, Illinois

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Astellas is announcing a Director, Clinical Science Operations opportunity in Northbrook, IL.

Purpose & Scope:

The Director Clinical Science Operations (DCSO) is responsible for Clinical Science (CS) activities focused on process improvement, inspection readiness and overall ensuring consistent application of quality control measures for activities conducted by CS. Additionally, this individual is responsible for oversight and management of the Astellas Risk Based Monitoring (RBM) Operations. In the activities for RBM, the incumbent will support all cross-functional teams for RBM implementation, strategy development and process maintenance. The DCSO acts as a fully independent lead for CS quality and RBM operational activities, leads efforts to expand and evolve the Astellas strategy for key operational initiatives including RBM, and provide oversight for other RBM operational roles including RBM Facilitators and RBM Project Managers. The incumbent requires limited supervision and day-to-day support from line management. The DCSO represents Astellas as the leading subject matter expert and advocate for clinical operations and RBM operational processes. This individual is responsible to understand and represent industry level best practices, identify improvement strategies and maintain a current overall knowledge of RBM.

The DCSO is responsible for providing strategic oversight for Astellas CS operations and RBM processes. This individual is responsible to ensure effective implementation of RBM processes by study teams, coordinating and delivering key messages related to operational and RBM oversight and coordinating applicable training activities to occur for the relevant functions globally. This individual is responsible to manage the RBM Oversight Committee and to collect and report the defined metrics relative to operational efficiency, quality and financial management to key stakeholders. This lead is responsible for ensuring that Astellas remains prepared for applicable regulatory agency inspection for clinical and RBM related activities. The DCSO will provide subject matter expertise to the development of processes and tools and the implementation of external partnerships with both vendors and industry associations (e.g., TransCelerate), when needed.

Essential Job Responsibilities:

The DCSO is the key leader for CS inspection readiness, process development and strategy development, including cross-functional leadership of Astellas RBM operations. This role is responsible to understand all key functional processes to have a broad understanding of the industry changes relative to key operational changes including RBM implementation. The DCSO is responsible for collaborating with appropriate functional stakeholders to establish and maintain inspection ready activities.

The following key activities are the responsibilities of the DCSO/Process Development, Improvement, Maintenance and Implementation:

  • Ensure effective implementation by project teams of process improvements and changes.
  • Maintain all associated quality documents relative to CS activities and the RBM process to ensure current and accurate.
  • Identify process improvement needs and facilitate required quality document updates.
  • Maintain the RBM Operations Manual and communicate changes as appropriate.

Training and Communication:

  • Oversee the development of any sustainable training required.
  • Ensure that sustainable training is current, accurately reflects the appropriate processes and appropriately deployed to the affected departments and job functions.
  • Identify and facilitate organizational and stakeholder communications as required for RBM activities.

RBM Oversight Committee (OC) Coordination:

  • Chair of the RBM Oversight Committee.
  • Responsible to coordinate key messages, issue escalations and other RBM related strategy changes for discussion by the OC.
  • Responsible to ensure timely resolution of any action items resulting from the OC review of the RBM progress.

Management of RBM Operations Team:

  • Assignment of RBM Facilitators
  • Review and alignment of algorithms for RBM support roles including RBM Facilitator, Central Monitor, and RBM Project Manager
  • Resource planning for RBM operational activities.

Inspection Readiness:

  • Develop plan for inspection readiness requirements for Astellas CS operations and RBM program.
  • Ensure all process documentation is current and reflective of the Astellas expected process.
  • Provide subject matter expertise for RBM and other key operational activities as required during a regulatory inspection.

RBM Project Implementation and Metrics Reporting:

  • Responsible for coordinating the establishment of operational success measures (quality, financial and efficiency) to demonstrate appropriate implementation and process development.
  • Responsible for collecting appropriate metrics relative to the financial impact of the RBM program

Participate in Astellas process improvement activities as required (e.g., review of new systems). Evaluate vendor capabilities as required.

Quantitative Dimensions:

Responsible for the development of operational strategy to support quality process management, inspection readiness and ongoing process improvement. Responsible to ensure the effective implementation and evolution of the Astellas RBM program.

Organizational Context:

  • Reports to Sr. Director CS Management Office.
  • Director reports -- could manage a team of up to 5 direct reports and provides functional oversight for RBM facilitators and Clinical Study Managers without direct line management responsibility.
  • Chair of the RBM Oversight Committee.

Qualifications:

Required:

  • BS/BA degree with at least 10 years clinical trial management or project management experience. Advanced degree (MS, PhD, PharmD) with 7 years of clinical trial management or project management experience.
  • Minimum 4 years people management experience.
  • Must have extensive expertise in developing operational strategies, strategic planning, process development and a strong knowledge of ICH GCP guidelines, and multinational clinical trial regulations.
  • Experience in people and project management, strategic planning and a strong knowledge of protocol and clinical drug development processes, clinical study design and study planning and management.
  • Regulatory submission experience desired.
  • Proven excellent leadership and subject matter expertise for key process improvement initiatives.
  • Previous experience engaging in regulatory inspections and/ or quality assurance audits, desired.
  • Proven skills in outsourced vendor oversight.
  • Strong cross-functional understanding of processes involved in drug development including regulatory affairs, safety/ PV, data management, clinical programming, biostatistics and clinical, with mastery level expertise expected in at least one of those disciplines.
  • Excellent verbal & written communication and critical thinking skills.
  • Proven leadership ability and effective at developing interpersonal relationships to work effectively with and oversee individuals across multiple functions, disciplines, and regions.
  • Fluent in English; low to moderate (5% to 20%) travel required.

*LI-BR

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