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Director, Global Companion Diagnostics Project Management - Basking Ridge, United States - Daiichi Sankyo
Description
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 16,000 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.
Summary:
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.
Responsibilities:
- 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.
Education Qualifications (from an accredited college or university):
- Bachelor's Degree biological sciences majors or other related discipline required
- Master's Degree biological sciences majors or other related discipline preferred
- PhD biological sciences majors or other related discipline preferred
Experience Qualifications:
- 7 or more years of relevant experience managing complex development projects required.
- 5 or more years work experience in pharmaceutical/diagnostics/CRO/consulting setting required.
- Experience in Companion Diagnostics preferred.
Completion of Project Management Training or training in Finance/Business is a plus.
Demonstrated track record of success working on a multidisciplinary pharma/diagnostic development team.
Knowledge of the IVD and/or clinical development process is a plus.
Knowledge of molecular diagnostics technologies, IVD manufacturers and pharma competitors, and market space is preferred
- Established expertise and hands-on experience with Microsoft Project, Word, Excel, PowerPoint, Outlook, SharePoint, and remote meeting tools such as WebEx, Live Meeting required
Travel
Ability to travel up to 20% 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.
