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.
The primary responsibility of the Global Companion Diagnostics Portfolio Leader will be to set the vision, define the objectives and provide global strategic leadership to a team of Global and Regional CDx Leads. The leader is responsible for a team that designs, executes, and oversees the global end-to-end delivery of CDx development and regulatory approval. The focus of this position will be on multiple ADC assets in late stage clinical development including the assets being co-developed with our Alliance partner. This leader will have accountability for driving the due diligence and selection process for identification of the appropriate CDx co-development and co-commercialization partners. This leader will work collaboratively with multiple internal stakeholders including members of CDx Leadership Team, Diagnostic Scientists, CDx Project Managers, CDx Operations Leads, Clinical Development, Regulatory and Business Development
- Provides strategic leadership to CDx project teams for the diagnostic development, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch. Sets direction and objectives for group. Works in close collaboration with peers in Global Companion Diagnostics Leadership Team and key cross functional stakeholders across the globe.
- Recruits, trains, mentors a diverse group of talent, and serves as group manager. Manages resources within Global CDx Leads team to meet the needs of the portfolio. Builds capabilities consistent with portfolio demands and operating model, considering needs across multiple assets. Focuses on developing regional CDx capabilities to support regional activities.
- Leads CDx Partner evaluation and selection activities and develops and maintains productive collaborations with existing and potential Companion Diagnostics Partners.
- Provides technical and strategic leadership in a highly matrixed Global R and D environment. Serves as member of Joint governance teams with Alliance partners and on various cross asset teams and operating committees such as CDx Program review committee, PRG and CDx JSCs. May also represent function on a GPT or lead a JPT as necessary.
- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally, represents DS in various Health Authority interactions for approval of CDx.
- Creates a forward-looking Diagnostic development strategy for the DS portfolio while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape.
- Identifies a strategy for selecting Precision Medicine Consortia for DS to participate in, contributes to and represents DS on these Cross-company consortia as a senior leader. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, and in support of pre-launch, launch and LCM activities as necessary.
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)
- PhD, MD, MD PhD or PharmD required.
- PhD in Life Sciences is preferred
- 10 or more years work experience in pharmaceutical or diagnostics industry required. Pharmaceutical industry experience is strong preferred.
- Demonstrated track record of success leading multidisciplinary pharmaceutical /diagnostic development teams.
- Understanding of the IVD Development Process, with direct experience with Companion Diagnostics Development.
- Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR.
- Experience with CDx regulatory submissions to the FDA and other health authorities globally required.
- Knowledge of drug development process and a strong understanding of how diagnostic development can shape drug development and commercialization, especially in oncology, is strongly preferred.
- Ability to travel up to 15%. Domestic and international travel may be required.
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.