Director, Translational Research and Biomarkers

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceuticals Co., Ltd. seeks a senior biomarker/genomics scientist to lead cross-functional teams in asset development with active biomarker projects and to drive integration of biomarkers into clinical trials.

You will help design translational plans, collaborate with external experts, and oversee multi-omics data analyses to support pharmacodynamics markers and patient enrichment strategies. The role emphasizes leadership, advanced genomics and biomarker expertise, and the ability to

Qualifications

• PhD or MS in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or other relevant scientific field.
• Managerial and supervisory experience.
• Proven experience with designing and conducting biomarker and genomics research experiments and reviewing and interpreting data to support drug development and improve clinical trial design.
• Strong experience with a broad range of biochemical, molecular and cellular assays and bioinformatics including RNA-Seq, Exome and Whole Genome Sequencing, high throughput proteomics, and multiplex flow cytometry.
• Ability to manage and collaborate on multiple projects in different stages of development under strict deadlines and fluctuating priorities.
• Experience in translating results published in the scientific literature to independently design, execute and interpret complex sets of experiments or procedures.
• Excellent verbal and written communication skills, including communicating and presenting complex results and ideas.

Responsibilities

• Leads and/or participates in internal cross functional project teams for asset development programs with active fluid biomarker projects
• Manages team responsible for the selection and integration of biomarkers into clinical trials
• Endorses mechanistic biomarker plans and subsequently manages the data generation for presentations and publications to increase brand growth
• Initiates experimental design discussions based on existing gaps in clinical trial data and aids in development of biomarker and genomic research plans in collaboration with Bioanalysis, Genomics, and Biomarker Research department head, project teams, and external opinion leaders
• Recommends to Sr leadership and defends clinical trial design elements, including indication selection, population selection, and biomarker assessments, as appropriate
• Engage external investigators and collaborators to ensure translational biomarker plans are robust and impactful
• Oversees the analysis of large datasets, such as multi-omics, to elucidate mechanism of action, identify fit‑for‑purpose pharmacodynamic markers, and enable patient stratification in clinical trials
• Contributes expertise to support business development due diligence projects
• Participates in feasibility for new technology tools
• Outsources services and implements and/or develops tools required to support biomarker and genomics research
• Recommends and defends emerging technology to support measurement in biological fluids in clinical trials

Skills

Biomarker research

Genomics research

RNA-Seq

Exome sequencing

Whole Genome Sequencing

High-throughput proteomics

Multiplex flow cytometry

Data interpretation

Project leadership

Cross-functional collaboration

Education

PhD or MS in Life Sciences

Tools

RNA-Seq

Exome sequencing

Whole Genome Sequencing

High-throughput proteomics

Multiplex flow cytometry

Job description

Job Summary

Otsuka is looking for a naturally curious, self‑motivated individual to join the Bioanalytical, Genomics, and Biomarker Research team. Innovative projects that focus on bringing solutions to clinical programs, such as -omics analysis for the elucidation of mechanism of action and identification and selection of mechanism‑based pharmacodynamics markers, patient enrichment approaches to improve clinical trial design, and genetic variant correlation with clinical assessments are just a part of what we invest our energy in. If you are looking for an opportunity to pioneer in the field of genomics and biomarkers in clinical trials that will ultimately impact the lives of patients, look no further.

Job Description

• Leads and/or participates in internal cross functional project teams for asset development programs with active fluid biomarker projects


• Manages team responsible for the selection and integration of biomarkers into clinical trials


• Endorses mechanistic biomarker plans and subsequently manages the data generation for presentations and publications to increase brand growth


• Initiates experimental design discussions based on existing gaps in clinical trial data and aids in development of biomarker and genomic research plans in collaboration with Bioanalysis, Genomics, and Biomarker Research department head, project teams, and external opinion leaders


• Recommends to Sr leadership and defends clinical trial design elements, including indication selection, population selection, and biomarker assessments, as appropriate


• Engage external investigators and collaborators to ensure translational biomarker plans are robust and impactful


• Oversees the analysis of large datasets, such as multi-omics, to elucidate mechanism of action, identify fit‑for‑purpose pharmacodynamic markers, and enable patient stratification in clinical trials


• Contributes expertise to support business development due diligence projects


• Participates in feasibility for new technology tools


• Outsources services and implements and/or develops tools required to support biomarker and genomics research


• 
  
  • Recommends and defends emerging technology to support measurement in biological fluids in clinical trials
  
  

Qualifications

Required

• PhD or MS in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or other relevant scientific field


• Managerial and supervisory experience


• Proven experience with designing and conducting biomarker and genomics research experiments and reviewing and interpreting data to support drug development and improve clinical trial design


• Strong experience with a broad range of biochemical, molecular and cellular assays and bioinformatics including RNA-Seq, Exome and Whole Genome Sequencing, high throughput proteomics, and multiplex flow cytometry


• Ability to manage and collaborate on multiple projects in different stages of development under strict deadlines and fluctuating priorities


• Experience in translating results published in the scientific literature to independently design, execute and interpret complex sets of experiments or procedures


• Excellent verbal and written communication skills, including communicating and presenting complex results and ideas

Preferred

• Knowledge of digital biomarker use in clinical trials


• Proficient in computational genomics and bioinformatic pipelines, including biological interpretation of results


• Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance


• Experience contributing to regulatory submissions and health authority interactions

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Application Deadline

This will be posted for a minimum of 5 business days.

Company Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

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