Director, Decentralized Clinical Trials CoE

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 role is a Director level manager within the global Clinical Science (CS) team. Primary accountability is to lead development and adoption of Decentralized Clinical Trials (including digital health technologies (DHT)) within clinical drug development programs. This role will define and own the CS DCT Strategy which includes DCT, including DHT vendor landscape assessments and program level feasibility (site and patient) assessments. The candidate will work closely with counterparts in data and technology focused roles, to ensure the end to end implementation and support of DCT capabilities, including business process execution through data acquisition and analysis.

They are responsible for input and planning information (Budgets, timelines and resources) as well as oversight and execution of activities for assigned support function(s).

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 between the clinical organizations in Japan and China for the relevant support functions. This position is a member of the Clinical Science Management team.

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) / functions to solve problems, 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 and resources within assigned support functions

• May participate in external interactions with regulatory authorities and/or external industry peers/experts for including participation in health authority inspections and internal business process/quality audits

• Recognized leader in standard 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 CS

• 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, including relevant service providers

Quantitative Dimensions:

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.

Organizational Context:

• This position reports into the Senior Director, Clinical Science or above and provides functional leadership and management of up to 10 employees globally.

• While this position resides in Development, the scope of responsibility for this role includes support of broader M&D functions, including Medical Affairs and Rx+.

Qualifications:

Required

• BA/BS degree with at least 12 years of experience (or 8 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development, direct clinical trial management experience is strongly desired

• Must have strong knowledge of clinical trial conduct, including, multi-center, global trials.

• Minimum of 2 years of direct people management experience

• 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 management/oversight of external providers (e.g. 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).

• Minimal (15-20%) travel required

Preferred:

• Advanced degree (E.g. PharmD, PhD)

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

#LI-SS

Category Clinical Science

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

EOE including Disability/Protected Veterans