Director, Clinical Bioanalysis

Location
Basking Ridge, NJ, United States
Posted
Mar 22, 2021
Ref
10715BR
Hotbed
Pharm Country
Required Education
Other
Position Type
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 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.

Job Summary:

The Director of Clinical Bioanalysis has the responsibility of providing strategic bioanalytical leadership for all phases of clinical development for 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 Integrated Summary of Immunogenicity.

Responsibilities:
  • Providing bioanalytical strategy recommendations to clinical development programs, especially in the early lead optimization and PoC phases. Providing knowledge input for emerging assay technologies.
  • Primary responsibility for scientific oversight the development and validation (as well as lifecycle management) of PK, PD and immunogenicity assays at CRO partner labs. Assist/facilitate resolution of assay method issues. Review and approve validation plan, method specifications and validation reports.
  • Primary responsibility for closely collaborating with clinical study teams in managing sample analysis at CRO labs. Responsible and accountable for bioanalytical study timeline and oversight of data quality. Manage/resolve sample analysis issues. Review/approve BA sample analysis study plan and reports. ensure compliance with appropriate SOPs and regulatory guidelines.
  • Responsible for providing standardized sample collection, storage and transmission specifications for use in clinical studies to ensure the integrity of samples and validity of subsequent sample assay. Work with study teams to ensure implementation of appropriate sample logistics, including meeting all appropriate labeling and legal requirements.
  • Author and review of bioanalytical contents needed for clinical study and regulatory communication and submission.
  • Establish, maintain and improve standardized working processes to ensure uniform and cost-effective practices in clinical bioanalysis.


Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • PhD or equivalent in analytical chemistry, biology, biochemistry, chemistry, pharmaceutical science or related scientific field required
  • 10 or more years' relevant industry experience including CRO monitoring is required
  • 4 or more years' experience in addressing inquiries from regulatory agencies regarding specific issues on bioanalytical methodology and when needed, formulating strategies for regulatory interactions is required
  • 4 or more years' experience with assay development for antibody-drug-conjugate (ADC) programs, as well as critical reagent development is preferred
  • 4 or more years' experience in clinical development 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.

Job Title
Director, Clinical Bioanalysis

City
Basking Ridge

Functional Area
QCP

State
New Jersey