Join a Legacy of Innovation 110 Years and Counting!
With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a \"Global Pharma Innovator with a Competitive Advantage in Oncology,\" Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and 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.
Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch
Leads CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships with Diagnostic Partner
Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure successful implementation of CDx and data collection
Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally
Creates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape
Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Minimum MS degree in life sciences; PhD in Life Sciences preferred
Minimum 3-6 years relevant work experience with PhD; 5-8+ with MS
Demonstrated track record of success working on 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 etc.
Knowledge of drug development process and a strong understanding of how diagnostic development can shape drug development and commercialization is strongly preferred
Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas
Strong strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs
Experience defining and maintaining strategic direction while ensuring successful execution of project details
Solid interpersonal and verbal and written communication skills with the ability to effectively communicate with individuals at all levels in the organization across various functions and locations
Ability to travel domestic and international up to 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. Job Title Associate Director, Companion Diagnostics - Lead
City Basking Ridge
Functional Area Global Oncology R&D
State New Jersey Associated topics: aseptic technique, biomedical, biopharma, health, healthcare, histotechnologist, immuno oncology, metabolism, nutritionist, physiology
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.