Head of Predictive Biomarker Strategy, R&D
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: January 25, 2026
|
|
|
Job Description:
Job Description Job Title: Head of Predictive Biomarker
Strategy, R&D Job Requisition ID: 779 Posting Start Date:
1/20/26 At Daiichi Sankyo, we are united by a single purpose, to
improve lives around the world through innovative medicines. With a
legacy of innovation since 1899, a presence in more than 30
countries, and more than 19,000 employees, we are advancing
breakthrough therapies in oncology, cardiovascular disease, rare
diseases, and immune disorders. Guided by our 2030 vision to "be an
innovative global healthcare company contributing to the
sustainable development of society", we are shaping a healthier,
more hopeful future for patients, their families, and society. Job
Summary We are seeking a strategic and experienced leader to lead
our Predictive Biomarker Strategy across the early oncology
portfolio, including but not limited to antibody-drug conjugates
(ADCs). The Head of Predictive Biomarker Strategy will play a
critical role in driving the predictive biomarker science across
preclinical and clinical stages, ensuring clinical, research and
translational research principles guide in the creation of
predictive biomarker candidates, decision regarding the necessity
of a predictive biomarker in a given clinical development program,
and final selection of the predictive biomarker for further
development as a companion diagnostic based on scientific,
clinical, regulatory and commercial considerations.
Responsibilities Lead and expand the Predictive Biomarker Strategy
function within R&D Develop biomarker strategies across
programs from discovery to late-stage development Serve as the
predictive biomarker thought leader on cross-functional project
teams Shape long term strategy for how biomarkers, patient
selection, response prediction and resistance biology informs
clinical strategy Collaborate with entire R&D functions as well
as commercial functions on predictive biomarker strategy and
selection of final biomarker for future development as a companion
diagnostic Manage the Predictive Biomarker Strategy team and report
to the Head of Early Development Oncology Drive integration of
multi-omics and pathology data (genomic, transcriptomic, proteomic)
into clinical development Interface with regulatory agencies
regarding Predictive Biomarker Strategy and CDx development
Qualifications Education Qualifications PhD, PharmD or MD in
oncology, molecular biology, immunology, or a related field
required Experience Qualifications 10 or more years in
biomarker/translational science in the biotech or pharmaceutical
industry or equivalent experience required Experience in late phase
clinical trials and in basic science: Prior experience in design
and conduct of phase 3 trials AND thorough understanding of basic
science research; OR Prior experience in advancing research stage
assets AND thorough understanding in design and conduct of phase 3
trials research required Proven track record of predictive
biomarker development in oncology, including scientific, clinical,
regulatory and commercial considerations necessary for
identification of predictive biomarker candidates and decision to
select a single biomarker for companion diagnostic development
Demonstrated experience or understanding of clinical trial designs
including standard-of-care control arm in future phase 3 trials
Demonstrated understanding or experience in operational aspects of
clinical trial design that incorporates predictive biomarker in
regulatory trials Strong understanding of regulatory and diagnostic
requirements for companion diagnostics Experience working with
external partners (biomarker technologies, academia) Effective
leadership, communication, and collaboration skills in matrixed
environments Experience with omics data analysis and bioinformatics
integration Knowledge of tissue-based assays (IHC, ISH), liquid
biopsies, DNA assays, RNA assays and molecular diagnostics 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. Salary
Range: USD$298,800.00 - USD$498,000.00 Download Our Benefits
Summary PDF Professionals
Keywords: Daiichi Sankyo, Elizabeth , Head of Predictive Biomarker Strategy, R&D, Science, Research & Development , Basking Ridge, New Jersey
