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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
This person will work cross-functionally to support the implementation of PRO instruments in clinical trials and observational studies. The person will work cross-functionally with other teams and senior leaders to support the clinical development and value creation of the company's oncology assets by ensuring the patient voice in clinical trials and real world studies. The work will focus on building rigor into the implementation of PROs in Daiichi Sankyo's clinical trial programs and ensuring the highest standards in collecting quality of life measures. Responsibilities include conducting user acceptance testing (UAT), monitoring of PRO compliance, align with CRO and ePRO vendors, and ensuring the rigorous PRO and QoL data collection. The person will work closely with the HEOR asset leaders and PRO lead to help in the implementation of the PRO strategy for Daiichi Sankyo's oncology products and with clinical development teams to ensure the highest quality in PRO data collection and HEOR endpoints.
- PRO Deliverables
- Ensure PROs are implemented appropriately in clinical trials, including support in writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials
- Support the incorporation of the product PRO strategy into the clinical operations by ensuring accurate data collection in line with the protocol and to optimize compliance by patients
- Aligning with CRO and ePRO vendors and ensuring the highest standards in QoL and HEOR data collection in clinical trials
- Support ePRO vendor with PRO instrument licensing where appropriate
- Monitor compliance rate in ongoing studies and inform HEOR asset lead and PRO lead regularly on status
- Conducting software developers user acceptance testing (UAT) and use of direct from patient digital health applications
- Support development and validation of PRO and HRQoL instruments
- Sign off site user guide of ePRO data
- Ensure appropriate patient instructions and guidance is disseminated
- Leading on the sponsor response to ongoing issues at sites with regards to the data collection of PROs
- Feedback on operational issues and align on actions with PRO lead and HEOR asset lead where appropriate
- Provide support with execution of other initiatives and research deliverables across the broader team
- Improve PRO Quality
- Propose improvement initiatives to ensure highest PRO data quality and mitigation strategies to limit issues with compliance in patient reporting
- Keep up to date with methodologies and guidelines (including those from Regulatory Authorities and Payers) and communicate findings to GOMAP and functional groups as needed
- Support Dissemination of PRO Data
- Support the preparation of relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in meetings at regulatory agencies, and provide robust evidence in support of submission activities
- Assist in the preparation of abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy
- Assist in promoting awareness of the importance of PRO data quality for the highest scientific and regulatory standards across Daiichi Sankyo’s drug development programs
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 required; Degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health Economics, Epidemiology, Pharmacy or a closely related discipline preferred.
- 4 or More Years Overall related experience required
- Minimum 3 years of experience in a PRO relevant role required
- Demonstrated experience with PRO data collection and implementation in a pharmaceutical environment
- Demonstrated experience in multiple projects management, specifically related to the operational issues of implementation monitoring and reporting of PRO data collection in clinical studies.
- Experience in pharmaceutical industry, particularly in drug development, with demonstrated experience in clinical trial planning and execution
- Clear understanding of the PRO requirements both by regulators such as FDA/EMA and payers/health technology assessments
- Experience with managing PRO development and validation projects
- Hands on experience in collecting PROs/COA endpoints including compliance reporting and instrument selection in oncology
- Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug development.
- Understanding of the evolving methods and regulatory and reimbursement environment with respect to PRO
- Strong communication skills, with stakeholder engagement from operations through executive levels
Ability to travel up to 30% Domestic and International Travel
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.
- Clinical Trial Protocols
- Clinical Trials
- Clinical Works
- Data Collection