Director of Study & ISR Operations

Astellas Pharmaceuticals - Northbrook, IL3.8

Full-timeEstimated: $120,000 - $170,000 a year
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Director of Study & ISR Operations opportunity in Northbrook, IL.

Purpose & Scope:
Operational leadership in the execution of MA-sponsored studies and Investigator Sponsored Research (ISR). Leads and implements the agreed strategic direction for MA sponsored studies globally, improving alignment between regions. Oversees the continued maintenance and evolution of this strategy, representing MA to key stakeholders to ensure that that the timeliness and quality of MA sponsored study deliverables are maintained.

Essential Job Responsibilities:
Leads the development and implementation of strategy and operating models (Development and Medical Affairs) related to the execution of MA sponsored studies globally. Improves alignment between regions and streamlines operations to improve quality and standardization of study deliverables.
Engages with MA leadership to develop the strategic direction for execution of MA sponsored studies, such as centralization of clinical operations within MA, vendor sourcing strategy, statistical and medical writing support, and engagement with other departments to align data generation expertise.
Implementation of this strategy, including resource planning, change management, and oversight of appropriate quality documentation and training.
Oversight of the maintenance of operating models. Establishes service level agreements and appropriate governance structures with stakeholders to ensure the timeliness and quality of MA sponsored study deliverables.
Leads the Study Operations Forum, MA Sourcing Strategy Steering Committee
Represents MA globally in strategic and operational discussions on MA study execution with Development and other external business functions such as Contracts & Outsourcing and Real World Informatics. Forms a collaborative relationship with these groups, providing accurate and timely information regarding the MA book of work to enable planning and ensures that stakeholders understand MA priorities and goals.
Directs alignment between regional Operations groups in the execution of studies, assisting with the transition of studies from one operating model to the next. Works proactively to identify and manage issues and risks, facilitating resolution.
Subject matter expert for MA study operations. When requested, represents MA globally on collaborative projects or process improvement initiatives with Development and other business functions, such as vendor selection and oversight, study management systems and tools.
Oversees and coordinates medical writing resource needs for MA studies globally (both CSRs & external disclosure requirements) and ensures the timely allocation of medical writing resources to studies
Collaborates with MA groups, External Disclosure team and Medical Writing in Development to ensure compliance and adherence to medical writing standards and timelines
Responsible for operational oversight of global ISR program. Together with the Senior Director Medical Standards & Excellence Metrics & Analysis group and Finance, develops standards and tools to track and monitor ISRs and to manage associated financial spend. Reports to MA Senior Leadership on operational status of ISR book of work.
Partners with the Executive Director, MA Operations and other Operations members to optimize departmental resources and processes to ensure successful outcomes of all project objectives
Accountable for meeting budget objectives, project goals and department priorities.

Organizational Context:
Leadership of strategy and operating models related to the successful execution of MA sponsored studies and ISRs. Implementation of models across entire portfolio of MA sponsored studies (e.g. approx. 60 new studies annually) with a total budget of $65 million and ISRs (annual budget of approx. $18-24million).
Management of projects within budget, including internal resource utilization and external vendors
Management of direct reports



Bachelor's Degree
At least 10 years pharma industry (or related) experience with the majority of this time spent in management/oversight of post-approval studies, including interventional and non-interventional study types and ISRs
At least 5 years' experience leading teams as part of project management, process improvement or strategic planning, with direct line management experience
Experience working within a medical affairs organization and a thorough knowledge of medical affairs processes and study types
Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development
Demonstrated leadership and collaboration in a matrix organization
Proven decision-making skills leading to successful outcomes
Excellent project management skills, including risk assessment and contingency planning
Strong written and oral communication
Clear demonstration of strong negotiation and influencing skills that lead to change. Proven ability to analyze, assimilate and interpret data then extrapolate key points and facts to present to key stakeholders
Competent presenter in order to influence both internal and external audiences
Strong ability to proactively evaluate existing strategies and processes and recommend appropriate changes
Strong ability to work effectively and collaboratively across a global organization, both cross-functionally and cross-culturally
Fluent in English language -written & verbal

Advanced degree in life sciences
At least 5 years in management experience, including mentoring employees within the department and other functional areas as appropriate
Direct experience working within a global function or working cross-culturally

  • LI- CH1
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Location IL, Northbrook
Category Medical Affairs