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Director, Clinical Trial Diversity

2 months ago

Trenton, United States Daiichi Sankyo Full time

Director, Clinical Trial Diversity & Patient Voice

in

Remote

at

Daiichi Sankyo

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This role may help to shape a strategic approach in patient voice and CTD as well as collaborate with various functions to ensure the GCO deliverables are met. The key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an Inclusive Research and Patient Voice Strategy and Infrastructure, 2) Identify innovative approaches, industry best practices, tools, and data strategies to support best in class diversity and patient voice planning, 3) Design, lead and implement the GCO delivery framework for diversity and patient voice plans 4) people manage in future. Responsible for the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

Responsibilities: Lead and implement the establishment and oversight of a GCO Inclusive Research and Patient Voice Strategy and Infrastructure. Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development (ie. Patient voice) that are effective, streamlined and are by design initiated at the optimal time in the clinical drug development process-Ensure GCO diversity related roles and responsibilities within external partners (e.g. CROs, specialty Vendors) are well defined, clear and aligned to goals set by related internal groups (e.g. patient advocacy, ID Office, field medical, regulatory affairs, etc.)-Establish and oversee indication or study specific demographic targets across the Inclusion Diversity (ID) spectrum and guide teams in how to operationalize the feasibility approaches. Partner with internal and external data/systems centers of excellence to identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of success to ensure maximum impact and efficiency in overall diversity and patient voice processes and output. -Provide oversight to ensure such processes are adhered to consistently and exceptions are appropriately managed including when executed by external partners such as CROs. Exceptions must be discussed with clinical development. Review, approve and/or drive related process related improvement to the diversity and patient voice space. This includes gathering cross functional feedback to support significant process improvement efforts related to process space. Present proposals for approval to appropriate leadership. Collaborate with medical affairs or the DAST to create, maintain and update the TA’s DI Toolkits based upon real time feedback, lessons learned, and enterprise-wide best practices. Reinforce DS commitment to inclusive clinical research by conducting presentations and trainings, where needed for CRO partners, vendors, or investigative sites on the importance of representative diversity in clinical trials and patient voice. Identify innovative approaches, industry best practices, tools, and data strategies to support best in class diversity and patient voice planning. Maintain relevant and current awareness of the evolving global requirements for diversity in clinical trials -Continually evaluate industry landscape and lead identification assessment of innovative approaches to diversity and inclusion as well as patient voice -Identify, build, and manage effective relationships with academic, corporate community and vendor partners -Provide oversight and be one of the key subject matter experts (SMEs) on Daiichi Sankyo's existing diversity and patient voice related portfolio of platforms, tools and systems. Design, lead and implement the GCO delivery framework for diversity and patient voice plans. Partner with the asset lead, GPTs, and study teams to establish and oversee Diversity Plans (DP) and patient voice on the indication and study levels, taking into consideration the epidemiology of the disease -Review applicable study specific clinical trial materials to ensure cultural sensitivity and health literacy guidelines are followed. Establish tracking mechanisms at the study team and clinical trial site level to proactively monitor diversity performance and implement mitigations as necessary -Leads the review and analysis of site level activities through targeted risk-based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable DS SOPS and procedures -Enable ways for GPTs and Study Management Teams to have conscious inclusion trainings, and tools for investigative sites to support their efforts in reaching diverse communities People Management: May manage staff which would include oversight, training and mentoring of employee and/or contractor-based staff/analysts to support the overall delivery of a clinical trial diversity and patient access strategy. Qualifications:

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications:

(from an accredited college or university) Bachelor's Degree bachelor's degree in a relevant field and a minimum of 7 years of experience required Experience Qualifications. 7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or clinical operations project management preferably with a sponsor company at a global level required. Proven track record of providing diversity and patient access related services and value to an organization preferred. Demonstrated success in working cross functionally in a global matrix; minimum 2 years’ experience in managing or supporting global cross-functional processes and contributed towards driving processes and oversight preferred. Experience interpreting quantitative data and analyzing metrics preferred. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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