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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 www.astellas.com .

This position is based in Northbrook, Illinois. 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 Head, Global Site Management and Monitoring (Late-stage) reports to VP Global Site Activation and Late-Stage Monitoring and is accountable for global site management and monitoring strategy and execution across the Astellas late-stage Oncology and Biopharma clinical trials portfolio.

This position is accountable for the strategic development, oversight, and maintaining the global network of key strategic clinical investigative site relationships who provide advice and execute work on the Astellas portfolio of clinical studies. The network of key strategic sites supports of both early and late-stage Clinical Operations across all focus areas with emphasis on early clinical development. Support functions in scope for this position may include:

+ Clinical program delivery

+ Monitoring

+ Business Operations (US, EU/UK, APAC) – includes staff onboarding, department performance management and enhancement, and departmental communication management

+ Collaboration with Clinical Science (Medical), Portfolio Leadership (Focus area leadership and Global Development Project Leaders), Medical Affairs, and Clinical Pharmacology Early Development

+ Legal Operations Vendor Strategy & Management

+ Process, Training & Development

+ Study Operations Standards - includes the overall study operational and support model

This role is responsible for input and strategic planning and maintaining relationships with key strategic global clinical trial centers who will provide consultancy advice and input as well as execute Astellas clinical development programs. This position will also support development of Confidentiality Disclosure Agreements (CDAs) and Master Service Agreements (MSAs) with these key strategic centers as well as maintain budget control over associated activities and processes necessary to oversee and maintain the site network.

This position will be responsible for development and implementation of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development and across the early and late stage (including MA and RX+, where applicable) clinical organizations for the relevant support function.

This position serves as a core LTmember of the Global Site Activation and Late-stage Monitoring function within COQSCD.

Strategic Leadership & Operating Model Development

+ Define, implement and oversee the processes and regional infrastructure required to build the first Astellas global site network and engagement strategy across the late-stage portfolio, with a focus on defined priority countries.

+ Lead and/or collaborate closely with the GSSMM LT functional heads to develop and operationalize the global study start up, feasibility/site selection and site management required to enable successful delivery of all late-stage clinical trials in partnership with Clinical Operations and other key internal stakeholders.

Essential Job Responsibilities:

+ Responsible for the oversight and execution of relevant support function strategies against established Astellas and industry standards. This includes effective communication, coordination and leadership of key business stakeholders (e.g. study teams, global medical leads, and focus area leaders) / functions to solve problems, build relationships, develop contingency plans to support timely completion of both drug and non-drug program goals and objectives.

+ Responsible and accountable for the development and management of budgets, timelines, relationships, and resources within assigned support functions.

+ May participate in external interactions with industry leaders/external industry peers/investigational sites/experts for advisory board meetings, site visits/interactions, and congresses.

+ Recognized leader in investigative site relationship management and operating procedures, internal business procedures (SOPs, Global Regulations, Ethics & Compliance, Outsourcing) and the application of procedures to the business to ensure adherence to quality standards for assigned support function.

+ Considered a Subject Matter Expert and key contributor/leader in department and cross-functional process improvements / initiatives, includes serving as the change management champion/lead within GSMM and the greater COQSCD organizations responsible for recruitment, development / career management and retention of staff. This includes ensuring appropriate training and oversight of adherence to Astellas policies and procedures.

+ May participate as a member of internal and external governance committees and panels, including relevant service providers, Key Opinion Leader advisory board meetings, and congresses.

Quantitative Dimensions:

Responsible for the preparation and management of functional budgets and resources and oversight of clinical trial investigative site relationships and institutional policies/procedures, and inter-workings.

This position is expected to work across both Early and Late-stage Clinical Operations support site network development and management across the entire M&D portfolio. It also requires strong collaboration M&D Development Heads and Medical Affairs to development and manage the Site Network and Engagement strategy.

Organizational Context:

This position reports into the VP, Global Site Activation and Late-Stage Monitoring within COQSCD. The Head, Global Site Management and Late-stage monitoring provides functional leadership and management of approximately ≥3 employees globally (i.e. NA, EU and APAC).

Qualifications

Required:

+ BA/BS degree with minimum ≥ 10 years of experience (or 8 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development, direct clinical trial management experience or contract research organization experience is strongly desired.

+ Must have strong knowledge of clinical trial conduct, including, multi-center, global trials and late-stage clinical development.

+ Experience in working and building relationships with Key Opinion Leaders and Investigative Research Sites across different global regions and countries.

+ Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant project and non-project support functions.

+ Demonstrated leadership skills and ability to effectively collaborate with cross-functional/cross-regional colleagues.

+ Demonstrated ability to successfully lead global process or system improvement initiatives.

+ Must have a strong knowledge of clinical development processes and ICH/GCP.

+ Experience in building relationships and management/oversight of external providers (e.g. clinical investigational sites, contract research organizations, functional service providers and other clinical suppliers).

+ Must have excellent interpersonal, written, verbal, and computer skills.

+ Fluent in English (oral and written).

+ Approximate (15-20%) travel required.

Salary Range

$175K – $235K (NOTE: Final salary could be more or less, based on experience)

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

+ 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

+ Referral bonus program

\#LI-SS

Category Site Activation / Late-Stage Management

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

EOE including Disability/Protected Veterans