Daiichi Sankyo US · 4 days ago
Head of Predictive Biomarker Strategy, R&D
Basking Ridge, NJ
Full-time
Onsite
Director/Executive
$299K/yr - $498K/yr
10+ years expDaiichi Sankyo is a global healthcare company focused on improving lives through innovative medicines. The Head of Predictive Biomarker Strategy will lead the predictive biomarker science across early oncology portfolios, driving strategies from discovery to late-stage development and ensuring alignment with clinical and regulatory considerations.
Health CareTherapeuticsWellness
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
Qualification
Required
PhD, PharmD or MD in oncology, molecular biology, immunology, or a related field required
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
Company
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.
10001+ employees
H1B Sponsorship
Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (25)
2023 (19)
2022 (12)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
2025-06-01
2025-02-18
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