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