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Director, Companion Diagnostics Lead

Employer
Daiichi Sankyo
Location
Remote by Design Home Office
Start date
Dec 11, 2023

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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, manages CDx development activities and deliverables in collaboration 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 and Experience Qualifications (from an accredited college or university)

  • PhD, PharmD or MD with a minimum of 5+ years relevant work experience in pharmaceutical or diagnostics industry. PhD is preferred.
  • Master's Degree with 8+ years of relevant experience will also be considered

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.

Company

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. 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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Company info
Website
Telephone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States

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