Director, Bioanalysis
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: February 25, 2021
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Job Description:
Director, Bioanalysis in Basking Ridge, NJ at DSI Job
DescriptionJoin 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:
PhDor equivalent in analytical chemistry, biology, biochemistry,
chemistry, pharmaceutical science or related scientific field
required
10 or More Years relevant industry experience including CRO
monitoring 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
required
4 ore More Years' Experience with assay development for
antibody-drug-conjugate (ADC) programs, as well as critical reagent
development required
4 ore 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.
Candidates with Disabilities Who Require Assistance Daiichi Sankyo,
Inc. provides reasonable accommodation in job application
procedures for qualified individuals with disabilities and disabled
veterans. If you have a disability that inhibits your ability to
apply for a position through our online application process or you
otherwise need accommodation in connection with the recruiting
process due to a disability, you may use the alternative methods
described below to contact us about your interest in Daiichi
Sankyo, Inc. and/or to request an accommodation. Daiichi Sankyo,
Inc.
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal
Opportunity Employment 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.
Keywords: Daiichi Sankyo, Newark , Director, Bioanalysis, Executive , Basking Ridge, New Jersey
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