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Astellas Pharma Senior Manager, Clinical Science CoE - Decentralized Clinical Trials 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 Decentralized Clinical Trials (DCT) Office. This includes DCT Processes and Standards, DCT Operational Implementation and Execution and DCT cross-functional coordination and collaboration.

They are 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 to support operational implementation of DCT solutions 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 DCT deliverables

  • Accountable for all activities related to DCT strategies. This may include:

  • 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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