Head of Site Management, Early Development

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ~~~ .

This position is based in Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The primary purpose of this position is to provide leadership and strategic direction in the creation, maintenance and execution of all Early Development global site monitoring and management efforts within Astellas and provides resource management and regional deployment for monitoring and site management within the Early Development portfolio for the execution and compliance of clinical trials. Within the Early Development portfolio, the position will be responsible for the strategy and execution of resource allocation including regional deployment and utilization of staff augmentation.

The Early Development Site Management Head will be responsible for overseeing the development and execution of the following activities across the Early Development portfolio with alignment and partnership with the Late-Stage Monitoring:

• Site monitoring & management strategies including strategies as they relate to risk-based approaches to site monitoring and management

• Site engagement and site relationship management

• Training content development and delivery to support site monitoring & management

• Monitoring oversight strategy

This position will be responsible for ensuring that the site monitoring and management delivered across the portfolio upholds quality, is cost effective, and facilitates robust site relationships. This position will ensure cross functional collaboration and regional strategies to facilitate effective site monitoring and management. The Head of Early Development site management will collaborate with the head of late-stage site monitoring and management to ensure consistent delivery of site monitoring and management strategies.

Essential Job Responsibilities:

• Leads all site management planning activities required to meet FY and multi-year goals. This includes leading Early Development Site Management Organization's annual, midterm, and long-term strategic planning, staffing and budget development processes and activities, as well as the department's day-to-day budgetary, financial and resource management.

• Leads development and implementation of resource growth strategy to ensure adequate site management in expanding study portfolio

• Oversees development, implementation and refinement of site management SOPs and standards globally for Astellas globally, across the portfolio; this includes processes and standards to ensure site quality, monitoring oversight, robust site relationships and inspection readiness

• Works across support functions to proactively identify, risk-manage and resolve issues that arise with study teams and within support functions

• Provides direction and oversight for efficient and compliant processes, procedures, and systems to support site management strategic planning

• Works with Internal Audit and Quality Assurance stakeholders to define QA/audit needs for site audits globally, provide feedback on the audit approach, track progress/results of Early Development Clinical Operations audits and support remediation activities

• Partners with peers ( EDCOLT leaders, Head Late Stage Management) on initiatives, activities and deliverables that ensure high quality site monitoring and management

• Leads and manages a team of 40+ members in Early Development Site Management

• Cultivate collaborations and relationships with external organizations to position Astellas as a competitive and responsible world class pharmaceutical company

• Represents Astellas at industry events and brings insights and best practices gained into the company to help shape strategy and further evolve site monitoring and management capabilities

Quantitative Dimensions:

• Responsible for an organization of approx. 40+ employees, globally.

• Responsible for overseeing, reporting and tracking on the Early Development Site Management activities.

• Contribute to overall management of divisional budget as it relates to site management and monitoring budgetary activities >15MUSD.

Organizational Context:

• Reports into Head of Early Development Clinical Operations and provides functional leadership and management of = 5 direct reports in the North America, Asia/PAC, and EMEA.

• This position will be a member of the Early Development Clinical Operations Leadership Team (EDCOLT) and will provide input into departmental structure, budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.

• As part of the Early Development Clinical Operations Leadership Team, the position will work closely with leaders across Early Development Clinical Operations, the asset teams, and Clinical Quality Assurance, to ensure strategic oversight and implementation of efficient operational site monitoring and management strategies and regional alignment wherever possible. The position will also collaborate closely with portfolio delivery teams to ensure optimal performance delivery of site management (including site relationship management) practices.

• Peer group Early Development Clinical Operational : Business Operations Strategy Lead, Portfolio Operations Leads, Head, Sample Operations and Site Network Lead

Qualifications:

Required

• 15+ years of pharmaceutical industry experience with at least 12 years of direct clinical trial management experience

• Demonstrated experience managing site monitoring and management teams with minimum 5 years in leadership level role

• Demonstrated experience working with clinical trial sites to ensure data quality and inspection readiness.

• Extensive expertise in developing site monitoring and management operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality, and legal aspects)

• Strong Therapeutic area knowledge and the ability to support the design and executive of clinical programs.

• Proven track record of experience working with contract resource organization, functional service providers and third-party vendors

• Proven track record of experience in multiple Therapeutic Areas or disease state/indications including life cycle management

• Recognized leader in standard business procedures and system utilization to support monitoring and site management, and the application of procedures and systems to the business. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of the clinical organization.

• Bachelor's degree in science or related area of study

Preferred

• Advanced degree (E.g., PharmD, PhD)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• RRSP 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

• Referral bonus program

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Category Early Development Clinical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans