Business Operations Manager

Business Operations Manager/Lead

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

This position is responsible for the execution of assigned responsibilities within the relevant Clinical Operations support function for both early and late-stage Clinical Operations.

Clinical Operational Excellence (COE) support functions in scope for this position and may include:

• Clinical Compliance
• Site Monitoring and Management
• Business Operations includes department performance management, metrics, enhancement, and departmental communication strategy & management
• Process, Training & Development
• Trial Master File
• Clinical Operational Standards
• Clinical Systems standards and management
• Site Start Up and Activation
• Country and Site Feasibility
• Accountable for management of budgets, timelines, and workload
• Developing strategic relationships between stakeholders and investigational sites
Lead initiatives to enhance site satisfaction and strengthen operational excellence

Reports to the Head, Global Site Management and Late Stage Monitoring or above. This position may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members.

Role and Responsibilities

• Manage and may lead the day-to-day operations within site monitoring and management function focusing on Clinical Site Manager training and oversight to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Manage and may lead functional and cross-functional internal teams.
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Responsible for implementation of standards for designated functional areas
• Responsible and may be accountable for all activities associated with relevant support function. This may include:
• • Support internal site monitoring and management function by evolving process, developing and delivering training, developing and implementing monitoring oversight and supporting monitoring functional management.
  • Manage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support and/or
  • Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab) and/or
  • Manage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or
  • Manage and provide operational support related to systems used by site monitoring and system/technology standards for the CO organization and/or
  • Management of CO QD changes and training related assignments/curriculum and staff onboarding activities
• Provide oversight and direction to team members for functional and study-related deliverables.
• Participate in process improvement and quality-related initiatives associated with study execution and deliverables.
• Support and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission.
• Coordinate engagement strategies while building strategic relationships with investigational sites and site networks.
• Collaborate cross-functionally to enhance site satisfaction, strengthen operational excellence and support effective study delivery.

Required Qualifications

• 5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree.
• > 5 years’ experience in site management, developing and maintaining partner and site relationships, site monitoring/ site monitoring oversight experience
• Proven skillset in developing and delivering training via various methods
• Must have knowledge of clinical trial conduct, including, multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Requires proven project management skills and leadership ability
• Creative and strategic thinker with hands-on problem solving ability – comfortable with operating in a dynamic, fast-paced, global environment.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.
Minimal (10-15%) travel required.

Preferred Qualifications

• Experience in working cross functionally and with external providers.
Experience with development & implementation of process improvement related initiatives.

Location and Working Environment

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

$125,090 - $178,700 (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

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