Clinical Digital Health Technology Strategy Director

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:

The Clinical Digital Health Technology (DHT) Strategist is a Director level individual contributor within the global Data Science team. Primary accountability is to lead development and adoption of digital health technologies (DHT) within clinical drug development programs. This role will define and own the DS DHT Strategy which includes DHT vendor landscape assessments, technology enablement plans, optimized digital dataflows and integrations, vendor oversight and associated Data Science related operational work processes to support DHT adoption by clinical drug development program teams.

The DS Clinical DHT Strategist will support the Astellas Decentralized Clinical Trials (DCT) initiative's technology needs for eSource, remote data collection and technology enabled services (e.g., eConsent, telehealth, etc.) as well as other Astellas digital health solution needs such as the clinical development of electronic surveys and digital biomarkers. The incumbent will also be responsible to drive the strategy and support for other key areas of innovation for Data Science. The individual will play an active leadership role in identifying and implementing new digital tools and associated work processes utilizing industry standards and methodologies. This may include Electronic Health Records (EHR) integration with DCT platforms/EDC/data warehouses, process automation, application of machine learning capabilities, data analytics and visualizations, etc.

This role also ensures that all digital health technology systems/platform(s) and processes follow global regulatory, data privacy and quality requirements.

The incumbent is a seasoned change champion, with strong experience in implementing program and enterprise level technology for Clinical Development / Medical Affairs. The individual is an industry level thought leader and is an active contributor to key external industry activities, focused on bringing and enabling industry level best digital health technologies and practices into Astellas.

Essential Job Responsibilities:

• Provides industry level digital health technology implementation expertise to inform and influence Development Project Core teams / Core Medical teams regarding design and execution of high value digital health solutions per the asset's Global Development Plan. Develops implementation and operational plans and provides support for digital health technology solutions for drug development programs / marketed products as a standalone component or part of an overall program level DCT implementation.

• Creates and manages the overall Data Science Digital Health Technology (DHT) strategic plan. This includes development of a suite of technology tools and their respective tool kits including the implementation framework from the process, systems, roles, regulatory, quality and change management perspective.

• Closely collaborates with the Clinical Science Center of Excellence (CS CoE) DCT Office to ensure technical, digital health components to enable DCT as defined in the DS DHT strategic plan are aligned with the overall Astellas DCT Center of Excellence DCT roadmap and TA asset needs.

• Leads the Astellas DCT workstream efforts for all technology enablement aspects of platform development and DCT implementation including data flows.

• Operational leadership for digital health system vendors and solutions, including supporting DCT toolkits with playbooks for teams (e.g., DCT platforms, eSource, mobile health apps, wearables/sensors, etc.).

• Develop, implement and align the DCT and digital health technology operational support model and associated training delivery plan to support the broader roll-out of DCT and other digital health technologies across the Development / MA portfolio and functions. A strong focus on change leadership is critical to drive organizational understanding and adoption.

• Collaborates closely with the Clinical Science DCT Office, IS, TA Heads, Medical Affairs, Privacy, Regulatory and other internal/external partners, to deliver program and enterprise level digital health solutions that enable the DS DHT strategy.

• Closely collaborates with IS colleagues to implement DCT platforms and digital health technology solutions. Leads system/technology work streams for digital technology tools for DS. Establishes the dataflow, architecture and implementation plan to enable seamless integrations, with the ability to share data/information with patients, sites and internal stakeholders.

• Actively contributes to key industry activities (e.g., TransCelerate), to ensure that Astellas is leveraging the latest innovations, technologies, tools, work processes, etc.

• Evaluates new or existing digital health tools (apps/platforms/devices/etc.) to identify and catalogue opportunities and risks for Astellas. Articulates business value and strategic advantage to piloting of new digital health technologies that drive innovation and adoption in how Astellas supports clinical trials.

• Accountable for system/technology performance and vendor oversight, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks.

• Accountable for creation and monitoring of the key performance indicators (KPIs) for DCT technologies and digital health technology vendors. Reviews and monitors key performance metrics and overall operational health of implemented digital health technology solutions in partnership and alignment with the CS CoE DCT office.

Quantitative Dimensions:

• The Director is accountable to support all drug-development programs and marketed products (Phase I -- IV) requiring digital health solutions and acts as the Data Science Lead for program level discussions at the Development Program Core Team / Core Medical team.

• The incumbent will also be accountable for developing and leading the long-term strategy for key data management digital health methodologies and technologies, and associated systems integrations for up to ten different systems and vendors.

• The Director is expected to provide technology and process leadership to the multiple vendors (approximately 8-15) supporting Data Science digital health technologies and to highlight any areas of risk to the DS Leadership team.

• The Data Management Director is accountable for the management and tracking of KPIs and other key study metrics, to ensure alignment to DS and M&D goals for all drug development projects / marketed products.

Organizational Context:

• Reports to Senior Director, Data Management Solutions. Collaborates closely with Directors of Data Management to enable digital health solutions implementations at the clinical program and trials level.

• Provides DCT and novel data collection subject matter expertise to clinical study teams, as needed.

• Closely collaborates with the Clinical Science DCT Center of Excellence team and MA.

• Independent worker, working under loose supervision of Line Manager.

• No direct reports but may oversee the activities of lower-level team members assigned to support digital health solutions to study teams.

• Closely collaborates with cross-functional Core Team team / Core Medical team members (e.g., GDOL, GSTATL, GDPL, etc.) or other cross-functional staff such as procurement, systems and IT staff as appropriate.

Qualifications:

Required

• BS/BA degree in a biological science, health-related or computer science field.

• 10+ years related experience in pharmaceutical, clinical research or health services industry with a minimum of 8 years' experience leading technology implementations for clinical trial execution.

• Industry-level expert with DHT solutions (eSource, wearables, EDC, and/or eCOA systems/devices), including implementation of such systems.

• Demonstrated success in execution of strategies for DHT, previous experience in implementing novel digital health technology solutions and driving change.

• Active contribution to inspections and major (vendor) audits. Solid knowledge of international regulations for clinical trials (e.g. GCP) and familiar with eSystems data integrity requirements.

• Strong cross-functional understanding of all aspects of clinical development, with demonstrated expertise expected in Enabling technology solutions for clinical data acquisition and management.

• Strong digital data flow experience (i.e., data processing and integration with platforms, data warehouses; data aggregation; etc.)

• Solid understanding of CDISC and other associated industry level data standards.

• Excellent verbal and written communication skills.

• Proven ability to work with and influence individuals across multiple disciplines in international environment.

Preferred

• Professional certification in a Clinical Development discipline.

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 Data Science

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

EOE including Disability/Protected Veterans