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Astellas Pharma Senior Manager, Clinical Science Center of Excellence, ICF in Northbrook, Illinois

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:

This position is responsible for the planning and execution of assigned responsibilities within the responsible Clinical Science support function with operational excellence.

The Sr. Manager COE will support Clinical Operations and Model team within the Clinical Science COE. In this role, the candidate will support Astellas in developing first in class process associated with Clinical Trial informed consent process. This role is responsible for supporting the study teams with ICF (Informed Consent Form) development and review, vendor process oversight, review of escalations while gaining input from other relevant Astellas functional areas such as legal/ data privacy and Decentralized Clinical Trial Office. This individual will be responsible for creating an ICF process that will align with current industry trends including electronic consent and brings to the position a strong working knowledge of site/ ethics committee and health authority trends.

Accountable for effective management of budgets, timelines, and workload (including distribution to support members, where appropriate) for assigned support function.

Essential Job Responsibilities:

  • Manage and lead the day-to-day operations within relevant support function 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 lead related functional and cross-functional teams (including external service providers)

  • Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools

  • Proactively identify and resolve issues that arise related to support function deliverables

  • Accountable for all activities related to the relevant support function. This may include:

  • Manage and Provide operational support in the creation, implementation, maintenance and optimization of patient centered approaches for clinical trials inclusive of Clinical Science approaches to Decentralized trials and/or

  • Manage Clinical Science Compliance related activities inclusive of holistic evaluation of CS related audit findings, execution of CAPA and process related effectiveness checks, and CS inspection readiness support and/or

  • Manage Clinical Science Vendor oversight/performance activities inclusive of vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, vendor issue escalation etc. and/or

  • Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CS business processes and service provider related operating models (CRO, IRT, Central Lab) and/or

  • Manage the sustainability and optimization of the CRO/Sponsor Partnership processes for Clinical Science and/or

  • Manage and provide operational support related to technology and data enablement for the CS organization and/or

  • Management of CS QD changes and training related assignments/curriculum

  • Manage and provide operational support in the creation, implementation, maintenance and optimization of TMF processes for clinical trials inclusive of eTMF system curriculum ownership.

  • Manage and provide operational support related to archiving of TMF records inclusive of TMF migrations and eTMF system enhancements.

  • Manage Cross Functional TMF compliance related activities inclusive of holistic evaluation of TMF Health and TMF inspection readiness support.

  • Manage and provide operational support in the creation, implementation, maintenance and optimization of DCT strategies approaches for clinical trials.

  • Manage the sustainability and optimization of DCT processes.

  • Participate in and/or manage DCT activities including collaboration with external study execution vendors (may include CROs, Central Labs, IRT etc.).

  • Participate in process improvement and quality-related initiatives associated with study execution and deliverables

  • Provide oversight and direction to team members for functional and study-related deliverables

Quantitative Dimensions:

Responsible for the preparation and management of functional budgets and resources (where appropriate) and oversight of related components of trial or support function budgets, timelines and resources.

Organizational Context:

Reports to the Associate Director, Clinical Science or above. This position may have direct reports (no more than 2) and provides oversight and direction to team members for deliverables and may provide direct supervision for contract team members.

Qualifications:

Required

  • BA/BS degree with at least 7 years of experience (or 5 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development, direct clinical trial management experience is strongly desired

  • 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

  • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

  • Fluent in English.

  • Minimal (10-15%) travel required

Preferred

  • Experience in working cross functionally and with external providers

  • Experience with development & implementation of process improvement related initiatives

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

  • Referral bonus program

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Category Clinical Science

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

EOE including Disability/Protected Veterans

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