Astellas Pharma Manager Clinical Science CoE, Clinical Compliance, Risk Based Monitoring 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.
Purpose & Scope:
The Manager Center of Excellence Clinical Compliance position is responsible for the execution of assigned responsibilities within the relevant Clinical Science support function with operational excellence
Support functions in scope for this position may include: Clinical Standards and Compliance (overall study operational and support model, Clinical Compliance and Clinical Legal Operations) and Vendor Operations and Performance Management (Vendor Governance and Portfolio Performance Management; Technology, Data Enablement and Standards; Clinical Trial Patient Centered Support, Clinical Safety Notifications, Departmental Resourcing, Staff Onboarding/Offboarding and Administrative Support).
Accountable for management of budgets, timelines, and team workload.
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 partners (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
Manage and lead functional and cross-functional internal teams
Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
Proactively identify and advance issues that arise related to support functional results
Responsible for all activities associated with relevant support function. This may include:
Manage the creation, implementation, maintenance and of patient centered approaches for clinical trials inclusive of Clinical Science approaches to Decentralized trials and/or
Manage Clinical Science Compliance related activities of comprehensive evaluation of CS related audit findings, execution of CAPA and process related effectiveness checks, and CS inspection readiness support
Lead Clinical Science Vendor oversight/performance activities and vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, and analysis of key performance measures, vendor issue resolution
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
Lead the sustainability and optimization of the CRO/Sponsor Partnership processes for Clinical Science
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
Reports to the Sr. Manager, Clinical Science or above. This position has no direct reports but may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members.
BA/BS degree with at least 5 years of experience (or 3 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development
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.
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
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
Category Clinical Science
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans