Director, Diagnostic Sciences, Global Companion Diagnostics

at  Daiichi Sankyo Inc

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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.
Job Summary:
The Director, Diagnostic Sciences will be responsible for end-to-end process for CDx Implementation in clinical studies. They will ensure that sample testing and data generation activities are completed in alignment with the therapeutic and diagnostic team needs. They will also support CDx analytical and clinical validation studies in collaboration with Dx partner, or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and partners and will contribute to design and execution of technical assessment of assays, vendors, and specialty laboratories. This individual will work in close concert with multiple internal stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development.

Responsibilities:

• Designs and leads clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions
• Responsible for implementation of clinical trial assays at Diagnostics Partners, reference labs and specialty testing vendors. Facilitates the development and implementation of standardized template requisition forms, scoring forms, and DTS documents
• Develops and implements a testing quality monitoring program, ensures consistent data monitoring and output across the asset portfolio, and aligned CDx partners. Implements procedures which will enable early identification of issues and discrepancies, creates mitigation strategies, preventive actions
• Supports development of Dx product portfolio under design and change control regulations (ISO 13485, ISO 20916, IVDD/IVDR, and QSR). Supports analytical and clinical utility validation of candidate clinical biomarkers used for patient selection and treatment monitoring. Drives additional prevalence and body of evidence studies as needed to supplement CDx partner activities
• Plays a critical role in identifying and evaluating performance of new technologies in collaboration with Translational Science, builds and maintains relationships with external partners such as CROs, current and potential diagnostic co-development partners. Contributes to RFP process towards selection of CDx assays and co-development partners.
• Represents Companion Dx Dept on non-project initiatives and project teams, manages project transitions, develops process improvements.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

• Master’s Degree Life Sciences required
• PhD/MD/PharmD Life Sciences preferred

Experience:

• MS with 7+ years’ experience or PhD/MD/PharmD with 5+ years’ experience required
• 5+ years of diagnostic/assay development experience within a pharmaceutical company, CRO or a diagnostic company required.
• Demonstrated track record of success working on multidisciplinary pharmaceutical/biomarker /diagnostic development teams required
• Broad knowledge and technical understanding of established and new assay technologies such as NGS, IHC, PCR required
• Technical and operational understanding of the IVD Development Process and an understanding of how diagnostic development can shape drug development preferred
• Expertise in companion diagnostics development and implementation of biomarker assays in support of multi-site global clinical trials is preferred.
• Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams involved in clinical biomarkers or clinical trial operations
• Understanding of the IVD Development Process, with direct experience with Companion Diagnostics implementation in clinical trials and companion diagnostics operations is a plus
• Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR
• Solid interpersonal and verbal and written communication skills with the ability to effectively communicate
• Strong organizational ability to coordinate multiple activities
• Awareness of cultural differences and ability to connect and collaborate with colleagues globally

Travel Requirements:

• Ability to travel up to 15% domestically or internationally

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

• Designs and leads clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions
• Responsible for implementation of clinical trial assays at Diagnostics Partners, reference labs and specialty testing vendors. Facilitates the development and implementation of standardized template requisition forms, scoring forms, and DTS documents
• Develops and implements a testing quality monitoring program, ensures consistent data monitoring and output across the asset portfolio, and aligned CDx partners. Implements procedures which will enable early identification of issues and discrepancies, creates mitigation strategies, preventive actions
• Supports development of Dx product portfolio under design and change control regulations (ISO 13485, ISO 20916, IVDD/IVDR, and QSR). Supports analytical and clinical utility validation of candidate clinical biomarkers used for patient selection and treatment monitoring. Drives additional prevalence and body of evidence studies as needed to supplement CDx partner activities
• Plays a critical role in identifying and evaluating performance of new technologies in collaboration with Translational Science, builds and maintains relationships with external partners such as CROs, current and potential diagnostic co-development partners. Contributes to RFP process towards selection of CDx assays and co-development partners.
• Represents Companion Dx Dept on non-project initiatives and project teams, manages project transitions, develops process improvements