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 accountable for the oversight, strategic input, and execution of work within the Patient Engagement and Clinical Strategy Team to lead development and adoption of Decentralized Clinical Trials (including digital health technologies (DHT)) for clinical drug development programs across early and late-stage clinical assets. This role will define and own the overall DCT Strategy including DCT and DHT vendor landscape assessments and program level feasibility (site and patient) assessments.
They are responsible for input and planning information (Budgets, timelines and resources) as well as oversight and execution of activities for DCT and DHT.
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 across the early and late stage (including MA and RX+, where applicable) clinical organizations for the relevant support function.
This position is a member of the PECS Management team.
Essential Job Responsibilities:
Responsible for the oversight and execution of DCT 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
Closely collaborates 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
Responsible and accountable for the development and management of budgets, timelines and resources
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 CO
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.
Responsible for the preparation and management of functional budgets and resources and oversight of DCT/DHT related components of trial budgets and timelines and resources for all clinical studies.
This position reports into the Patient and Clinical Strategy Head, Clinical Operations or above and is an individual contributor role but may have direct reports in the future.
BA/BS degree with ≥12 years of experience (or 6 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.
Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant non-project support functions.
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
Advanced degree (E.g. PharmD, PhD)
Direct people management experience
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 Engagement and Clinical Strategy
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans