Job Information
Astellas Pharma Clinical Operations Systems Lead (Associate Director) in Northbrook, Illinois
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope:
The position is responsible and accountable for managing activities related to business and operations processes and systems utilized by the Functional Unit. This position may include oversight of the relationship with vendors within the Functional Unit, leading the creation of the annual plan and objectives in collaboration with senior leaders and responsible to oversee successful execution and delivery and/or ensuring Functional Unit is inspection ready at all times and that procedures, training and inspection readiness activities are being actively supported and managed across Functional Unit.
Role and Responsibilities:
Contributes to the strategic direction of the clinical systems team including support of new technology deployment, enhancements and establishing data quality standards/oversight.
Ensures successful execution of training to functional team members on clinical systems and processes.
Identify new technology needs, support budget evaluation and business case development to launch technologies for the Functional Unit.
Work cross functionally to represent the technology needs for clinical trial operational execution.
Contributes to all eTMF processes including systems management, TMF migrations, document management processes, TMF compliance processes, archival processes and liaison with records and information management teams and regulatory authorities.
Supports all aspects of operational and process standards to ensure effective implementation, adaptation of process, oversight of process efficiency and identification of issues and risks.
Engages cross functional teams as needed to ensure efficiency and quality of vendor performance against Astellas expectations.
Required Qualifications
Bachelor’s Degree required; MS degree preferred
Minimum 7 years of relevant work experience required
At least 5 years of pharmaceutical industry experience and good understanding of responsibilities and processes in one or more DS functional areas
Portfolio planning, forecasting, and budgeting skills and experience
Quality, compliance and/or inspection/audit experience
Familiarity with PM methodology preferred
Expert knowledge with clinical trial operational data and applications (i.e. Vault Clinical), including strategy .
Prior experience with UAT testing, UAT test scripts, and preparing UAT data.
Prior experience with enterprise system implementation or major enhancement build out.
Prior experience as a business process owner or administrator of clinical operations systems.
Prior experience with business requirements specification documents.
Preferred Qualifications:
Highly preferred to have experience with data governance – application or enterprise.
Highly preferred on data flows from CRO data integrations – Milestones, reference data, or site data (organizations, locations, persons).
Highly preferred to have admin level support in operational applications.
Highly preferred to have previous contributions to System Lifecycle Management process and documentation.
Highly preferred to have experience with authoring job aids and business process documents.
Highly preferred to have experience with measuring and managing data quality metrics and compliance.
Preferred to have experience as a user or implementation of portfolio and project management systems.
Preferred to have experience with development or specifications for dashboards, reports.
Preferred to have experience as a user or implementation with site training solution.
Preferred to have prior experience with a clinical trial execution role (clinical trial lead or manager, clinical research lead or manager)
Preferred to have prior experience implementing AI use cases for clinical trials.
Location and Working Environment
This position is based in Northbrook, Illinois. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
What awaits you at Astellas?
Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Company fleet vehicle for eligible positions
Referral bonus program
#LI-SS
Category Strategic Business Operations & Execution
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans