Astellas Pharma Senior Director, Clinical Science CoE Patient Centricity 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 will oversee and provide strategic direction for Astellas' Clinical Trial Patient Centered support functions, including Decentralized Clinical Trials and Diversity and Inclusion.
This position will be responsible coordination of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development and between the clinical organizations in Japan and China.
This position may be a member of the Clinical Science Leadership Team (CSLT) and will provide input into budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.
Essential Job Responsibilities:
Accountable for the effective oversight and execution of relevant Patient Centered strategies within study teams. This includes effective communication, coordination and leadership of key stakeholders / functions to ensure effective support strategies, solve problems, develop contingency plans and to support timely completion of both drug and non-drug program goals and objectives.
Responsible and accountable for effective management of budgets, timelines and resources within responsible support functions.
Interacts with key cross-functional stakeholders for the coordination of problem solving and contingency planning to assure project progress and timely completion of deliverables according to agree upon goals and objectives
Recognized leader in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Considered a Subject Matter Expert and key contributor/leader in department and cross-functional process improvements / initiatives.
May represent Clinical Science as a member of internal and external steering/governance committees, as appropriate for support functions.
Responsible for the preparation and management of functional budgets and resources and oversight of related components of trial budgets and timelines and resources for all clinical studies.
This position reports into the Senior Vice President / Executive Director, Clinical Science and provides functional leadership and management of up to 5 employees, with responsibility for approximately 15-20 employees globally.
While this position resides in Development, the scope of responsibility for this role include support of broader M&D functions, including Medical Affairs and Rx+.
BA/BS degree with at least 15 years of experience in pharmaceutical drug development, direct clinical trial management experience is strongly desired.
High performance as a Director or equivalent role with responsibility for relevant non-project support functions.
Must have strong knowledge of clinical trial conduct, including, multi-trial, Phase 2/3, global trials.
6 years of direct people management experience
Must have demonstrated experience in leading a cross-functional team in relevant support areas to ensure delivery of services in support of complex clinical programs and participated in a regulatory submission and associated inspections.
Significant experience in management/oversight of external providers (e.g. contract research organizations, functional service providers and other clinical suppliers)
Must have excellent interpersonal, written, verbal, presentation administrative and computer skills. Effectively present to leadership.
Fluent in English (oral and written).
Moderate (25%) travel required
- Advanced degree; Management experience in multiple clinical operations positions
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
Category Patient Centricity
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans