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 15,000 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 Director of Clinical Bioanalysis has the responsibility of providing strategic bioanalytical leadership for all phases of clinical development for small molecule and biological therapeutic programs and participate in strategy implementation. This position will work closely with CRO partners, and provide scientific oversight, for development and validation (as well as lifecycle management) of PK, PD and immunogenicity assays to support a diverse portfolio of clinical programs. The position will collaborate with clinical study team and external partners and be responsible for managing clinical sample analysis at all stages of development, ensuring that bioanalytical studies are conducted in a timely manner and in compliance with scientific principles and global regulatory standards. This position has the responsibility of authoring and reviewing bioanalytical sections of clinical and regulatory documents (IND, IMPD, NDA/BLA/MAA, IB, CSRs), including sections of module 2.7.1 and 2.7.2.
Responsibilities:
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)
Experience Qualifications:
Travel:
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.
br{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Join a great team, with great benefits, and have a rewarding career! Sienna Systems is...
Apply For This JobAbout the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and...
Apply For This JobJob DescriptionAt Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the...
Apply For This JobCompany Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Job no: 524035 Work type: Staff Location: Long Beach Categories: Unit 9 – CSUEU –...
Apply For This JobCompany Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious...
Apply For This Job