Biomarker Lead

Job Description Summary

As a BML, you will define the biomarker strategies and plans for a set of programs/projects, defined by asset or by indication, from early to later stage clinical development. You will also build external collaborations with academia or clinical sites to advance the knowledge around translational sciences and biomarker solutions focused on diseases, indications or pathways. The BML will be responsible to translate the preclinical discovery efforts into a clinical fit for purpose plan, as well as develop and mature the clinical biomarker plans as the program progresses through the various phases. The BML will oversee the integration into clinical protocols and lead the review and discussions at the different teams and boards. Finally, the BML can lead a matrixed biomarker team of scientific experts to build on the biomarker strategies and plans.

Job Description

Major Accountabilities

• Acts as BMD strategic and scientific leader in Japan at project or collaboration level to lead
  biomarker strategies and plans with the various local and global team members.

• Develops deep understanding of the translational biomarkers for a project/program (and associated clinical studies), focused on compound, disease, target, and pathway biology.

• Establishes scientific partnerships with local KOLs around biomarkers and translational research.

• Supports health authorities’ interactions around biomarkers and translational research.

• Ensures alignment and connectivity with other BMLs, therapeutic area leads and heads across assets, indications, and therapeutic areas.

• Partners with Biomarker Study Experts (BSE) and BMD Line Function Subject Matter Experts (SMEs) on the study strategic planning, and BM implementation.

• Is responsible for the contextualization and interpretation of the biomarker data including CSR review.

• Cooperates closely with Therapeutic Area Biomarker Head (TABH) or Therapeutic Area Biomarker Lead (TABL) as well as BMD Line Functions to enable the development of project/study level biomarker strategy and plans, implementation, contextualizing, and interpretation.

• Is an enterprise partner and strategic leader in the matrix environment, able to integrate and represent projects in the internal/external scientific discussions and initiatives.

Education/Experience:

• PhD, MD, MD/PhD, or MS degree is required.
• Good understanding of biology and translational research that can be applied to questions of patient’s selection, enrichment, dose selection, efficacy and response, disease progression, mechanism of actions, among others.
• Scientific excellence supported by academic and/or industry career track, and/or high-quality publications; clinical and/or biological expertise.
• Significant relevant experience after your MD/PhD/postdoc including drug development, clinical research/development, or translational research.
• Track record of contributions to clinical programs and studies in pharma industry (or biotech) is strongly preferred.
• Experience and familiarity with quantitative research and data is preferred, examples include biostatistics, omics profiling, AI/ML, bioinformatics, computational biology, clinical imaging, machine learning, or data science.
• Proven success in leading and partnering in multidisciplinary matrix teams across Pharma/biotech, or academic institutions.
• Creative and innovative leadership, experience in balancing big picture thinking with detailed analyses and operational aspects.
• Well-developed interpersonal and leadership skills with strong presence and ability to influence and navigate large organizational structures as well connect and network with KOLs.

Languages:

• Fluent Japanese (oral and written), Fluent English (oral and written)

Skills Desired

Data Analysis, Hypothesis Testing, Problem Solving, Structural Biology