Senior Director, Global Companion Diagnostics Lead

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary:

The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo’s Oncology Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics.

Responsibilities:        

• Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require a CDx for drug registration or for any project with CDPs containing multiple registrational clinical trials and are extensively exploring the predictive nature of potential CDx assays.  Leads CDx project teams for the diagnostic, in full alignment with Global Project Teams (GPT) covering all areas from CDx assay development through CDx approval and launch.     
• Creates the CDx development strategy, including partner evaluation and selection for a registrational phase project.  Manages CDx development activities and deliverables in collaboration with diagnostic partner across all clinical trials within the project, including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines.     
• Collaborates wtih Regulatory Affairs to develop CDx submission strategies.  May represent DS in various Health Authority interactions for the drug trials or for approval of CDx.  Keeps abreast of regulatory and policy updates in the external environment and understands the competitive landscape.  Proactively shifts CDx strategy to account for external shifts.     
• Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, and in support of pre-launch, launch and LCM activities as necessary.     
• Direct line management responsibility including developing and mentoring of Managers, Associate Directors and Directors.     
• May serve on CDx department extended leadership team.     

Qualifications: (What are the minimum requirements for the position?)

Education:

• PhD, MD or PharmD - minimum of 12 years’ experience or MS - minimum of 15 years of experience or BS/BA - minimum of 19 years of experience required

Experience:       

• Demonstrated track record of success working on multidisciplinary, international pharmaceutical development teams
• Experience with CDx regulatory submissions to the FDA and other health authorities globally.
• At least 4 years of companion diagnostic development experience within a pharmaceutical company.
• At least 2 years of experience managing direct reports.

Competencies:

• Ability to lead in a highly collaborative global environment with stakeholders from multiple functional areas
• Strong strategic leadership skills with an ability to define, prioritize and balance team responsibilities in accordance with business and team needs
• Strong interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams, both internal teams and alliance partner teams, and with all levels of management, including senior management, across various functions and locations
• Broad knowledge and understanding of established and new assay technologies.  Ability to strategically think about how to incorporate new technologies into the drug development process.
• Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization.
• Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx members.
• Ability to influence without authority within the organization.
• Ability to inspire and to lead direct reports.

Travel: Domestic and international may be required: 15%

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.

Salary Range: