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Executive Director, Global Head of Regulated Clinical Bioanalysis

3 months ago

Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

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 purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient implementation, and drives continuous improvement, facilitate/oversee global functional team collaborations. The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external partnerships to achieve the objectives of the global regulated bioanalysis group. The global head will also set the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the strategy for new technology. This position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and has managerial experience. This position will be a core member of the QCP Leadership Team and contribute to department vision, direction and future investments.
Responsibilities
- Oversees bioanalysis strategy from global development and global regulatory perspectives
- Facilitates/oversees global functional team collaborations, maintains relationships
- Provides significant mentorship and people development
- Evaluates/sets strategy of new technology; Oversees implementation
- Sets standards (industry best practices), ensures implementation, drives continuous improvement
- Be a core member of the QCP LT and provide input to department vision, direction and future investments
- Contributes to portfolio, in-licensing and relevant business development


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)
- PhD required PharmD required

Experience Qualifications
- 15
years of industry experience required
- Internal and/or external managerial skills preferred

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.

Estimated Salary: $20 to $28 per hour based on qualifications.