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.
The Patient Reported Outcomes (PRO) Director, will serve as the PRO subject matter expert and be accountable for management and oversight of Daiichi Sankyo (DS) PRO projects and activities. He/she will lead the development and execution of the PRO component in clinical trials and coordinate the PRO strategic plans for each asset, to optimize the clinical, economic, and patient-centered value proposition of DS oncology products within various disease states. The PRO Director will work cross-functionally with other internal functions (e.g. HEOR, Clinical Development, Biostatistics, Marketing and Medical Affairs), as appropriate, and will ensure that PRO strategies and tactics align with the overarching HEOR and product plans. The PRO Director will liaison with HEOR/PRO personnel within the company's alliance partner companies who have responsibility for DS oncology products outside across all regions.
Reports directly to the Vice President and Global Head of Oncology HEOR and RWE and has the responsibility to ensure robust global PRO strategies, tactical plans, and strong technical capabilities to implement PROs across the Daiichi Sankyo ADC portfolio. The position will be a key and visible expert leader, he/she will engage the R&D, Clinical, and Medical Affairs teams to drive the PRO evidence strategies to ensure an effective use of PROs tools and methods. The PRO Director will provide strategic leadership and specialized technical expertise to support the HEOR asset leads regarding the development of the PRO strategy and tools in clinical trials and real world evidence studies. He/she will also provide consultation and support for PROs that will support registration, reimbursement, and differentiation of Daiichi Sankyo oncology assets in early development.
- Work collaboratively with clinical development colleagues to incorporate appropriate PRO metrics/endpoints into clinical trials across the various phases of product development
- Give input to FDA briefing documents related to PRO label discussions as needed
- Develop and cultivate relationships with key external experts and payer influencers in clinical practice, academia, and the commercial setting to identify and discuss PRO-related topics important to Daiichi Sankyo, as well as developing strategic partnerships and research collaborations with key external experts, healthcare policy makers, payers, and various academic and community oncology settings to support PRO strategies
- Propose and lead the development of appropriate PRO data dissemination plans and communicate PRO evidence via publications and conference presentations in collaboration with cross-functional teams
- Recommend PRO data in HEOR strategies and tactical plans and ensure the appropriate implementation of PRO data collection in clinical trials
- Maintain awareness of the HEOR landscape, especially as it relates to oncology and global HEOR requirements, PRO guidelines, regulatory legislation, clinical guidelines, best practices, etc, and inform internal stakeholders about technical aspects related to PROs
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)
Master's Degree in a relevant discipline (e.g., health economics, medicine, pharmacy, public health, epidemiology) required
PhD or Doctorate level degree preferred
- 10 or More Years Minimum of 10+ years’ experience in the healthcare or pharmaceutical industry, 8 of which must be working with PROs required
- Understanding PRO methodologies across different phases of the product life cycle, and demonstrated experience with implementing PRO data in regulatory submissions is required
- Track record of successful application of PROs with key external stakeholders (e.g., FDA, GBA, etc.) in major international mark
- Knowledge and experience of Oncology therapy areas is essential
- Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including clinical, regulatory, scientific, operational, and commercial aspects of drug development. Uses knowledge to the organization’s advantage; generates new ideas and enables the organization to improve business performance.
- Demonstrates understanding and (advanced) knowledge of PRO methods and HEOR, and the issues and challenges of applying these alongside clinical studies in drug development, and applies this knowledge to design PRO strategies and HEOR studies
- Demonstrates deep understanding of the commercial and market access policy environment across major markets and harnesses this knowledge to design effective PRO evidence development strategies to support optimal market access for DS medicines
- Strong influencing skills and ability to navigate in a matrix organization, with proven ability to work cross-functionally, build coalitions and develop strong partnerships across functions
- Demonstrates strategic thinking, team leadership, and ability to travel up to 30%
- Experience within a pharmaceutical industry, consulting, or equivalent organization involved in research and development of healthcare technologies and/or delivery solutions
- Outstanding writing and presentation skills and ability to work under pressure, to take accountability for business challenges, think strategically and tackle complex problems
- Intellectual curiosity and ability to identify trends and emerging patters in areas such as RWE, HEOR, HTA assessments, Market Access, and Healthcare delivery and payer requirements.
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.
- Public Health
- Best Practices
- Drug Development
- Pre Clinical Development