Astellas Pharma Director Clinical Science Excellence in Northbrook, Illinois
Purpose & Scope:
The Director of Clinical Science Excellence (DCSE) is the principal owner of Operational Excellence which is one of the 3 pillars within the Clinical Science Center of Excellence (COE). Main purposes of the role include:
- Lead the implementation, maintenance, sustainability and ongoing optimization of the new Global Study Operating Model. Provide critical input evolution of sponsor study oversight model.
- Accountable Business Lead for all Clinical Research Organization (CRO) Partnership and CRO related operations for Clinical Science
- Accountable Business Owner of Partnership and Relationship level Operating Manuals and primary Business Liaison with CRO Providers for Clinical Science.
- Primary Liasion with Senior Leadership both within CS as well as across Medical and Development (M&D) and non-M&D Functions to support implementation of operational excellence within the Global Study Operating Model as well as more broadly across CS
- Accountable for ensuring Global Study Operating model is congruent with best industry practices, adheres to regulatory requirements along with extrapolation of process improvements to the broader Clinical Science Organization.
- Member of Astellas governance and technology teams as it relates to CRO Relationship/ Partnership to strategically support Global Study Operating Model, and specifically Sponsor Oversight activities.Reports to Senior Director, Head of Clinical Science Center of Excellence. Contributes to the implementation of the Clinical Science mission, Clinical Management Team, Non-project initiatives as requested, and the 1-3 year strategic plan.
Essential Job Responsibilities:
The DCSE is the leader of Operational Excellence activities, one of three areas of focus within the COE. Key to this role is independently leading the implementation, execution, sustainability, and optimization of the global study operating model along with application of operational excellence more broadly across CS. This role is the responsible owner for the ongoing maintenance, review, and optimization of CRO partnership/relationship operating and oversight model, and associated documents to enable clinical teams to efficiently, effectively, and compliantly execute and oversee clinical studies. The DCSE will be expected to independently collaborate with Sr. Leaders and functional stakeholders to establish and maintain the model.
The following key activities are the responsibilities of the DCSE:
Owner of the Partnership/Relationship Study Operating and Oversight Manual(s)
- Responsible for the delivery of final published manual(s)
- Primary business liaison with CROs; participate in routine partnership/relationship meetings
- Responsible for the ongoing maintenance of Operating Model and associated documents
- Responsible for process improvements, commitments, and scope changes within the operating model
- Responsible for gap analysis as the operating model evolves, and creation/revision of documents associated with the operating model
- Reviewer, signatory of final and revised manual(s) and relevant components
Training and Communication
- Oversee the development of any relevant sustainable training required within Clinical Science.
- Ensure that sustainable training is current, accurately reflects the appropriate processes, and is appropriately deployed.
- Identify and independently facilitate organizational and stakeholder communications as required activities.
Study Operating Model Implementation Owner
- During transition periods, participate in the assessment for interim process implementation
- Responsible for Overall study transition plan upon completion of study operating model build
- Develop and report on implementation metrics , including success measures
- Responsible for standardization/harmonization globally
- SME/ Point of Contact as it relates to Study Operating Model for Regulatory Inspections
- Implementation of process changes and optimizations to support health and longevity of global study operating model
Serve as voice across the business to support sustainability of model, updates to operating model documents, and process optimization
- Point of contact for other M&D (e.g. CRQA, RA, PV) and non-M&D Leaders (e.g. Ethics and Compliance, Legal, Clinical Pharmacy) as it relates to global study operating model and broader operational excellence activities within CS
- Primary internal liaison with Japan Asia Clinical Development Leadership for global study operating model
- First line of escalation within CS for CRO relationships around resource gaps or performance concerns if not resolved within the project team
- Primary CS liaison with PRSM relative to CRO relationships
Member of Technology team
- Support assessment and implementation of technology related activities for Clinical Science associated with the operating model
- Align on system implementation requirements and timing as it relates to global study operating and oversight model
- Assist with prioritization of system upgrades, changes within global study operating model
- Align on the development, implementation of new metrics
- Maintain metrics library for CS
Independently responsible for implementation and continuous maintenance of operational excellence activities inclusive of a global study operating model that allows teams to efficiently, effectively, and compliantly execute and oversee clinical studies. Responsible for overseeing the preparation and management of budgets, resources, and timelines to support study operating model and operational excellence related activities. Input and approval into departmental and vendor budgets.
Reports to the Senior Director, Head of Clinical Science Center of Excellence. Collaborate effectively globally with Clinical Science, Japan Asia Clinical Development, Medical Science, Data Science, Legal, QA, Regulatory, and IT departments. Ability to influence peers and senior leaders in same function, also in other sites; influence other peers and senior leaders inside and outside of Development.
- BS/BA degree with a minimum of 10 years clinical development related management or project management experience.
- Minimum 4 years direct or matrixed people management experience.
- Must have extensive expertise in developing operational strategies, strategic planning, process development
- Proven experience in leading and implementing process changes within a matrixed organization.
- Experience in people and CRO/vendor management, strategic planning and a strong knowledge of clinical drug development processes, clinical study design and study planning and management.
- Strong knowledge of ICH GCP and clinical trial regulations.
- 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 interacting independently at a Senior Leader level across multiple functions, disciplines, and regions.
- Fluent in English; low to moderate (5% to 20%) travel required.
- This is a Northbrook based position
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Global Development Operations