Associate Director, Translational Research and Biomarkers
Otsuka Pharmaceutical Companies (U.S.) · Massachusetts, United States · 1 wk ago
Analyst$169k/yrFull-time
About the role
The Associate Director of Translational Research and Biomarkers is an integral member of the Translational Biomarkers team and plays a pivotal role in advancing drug candidates from preclinical research through clinical development. This position requires expertise in immunology and nephology, clinical translational research, and data analysis, visualization and interpretation.
Responsibilities
- Participate as a key member of cross-functional project teams supporting asset development programs with active biomarker initiatives.
- Collaborate effectively within a cross-functional, matrixed environment—including Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams—to refine translational hypotheses and deliver high-quality, program-critical outputs on accelerated timelines.
- Contribute to the design and advancement of scientifically rigorous biomarker and clinical development strategies, including indication and patient population selection, TE/PD biomarker integration, and MoA hypothesis development.
- Contribute to the selection, outsourcing, and execution of biomarker assays in biological matrices, and manage external vendors to ensure quality and timeliness.
- Develop and implement biomarker analysis plans and support high-quality data generation for interim and final clinical analyses.
- Ensure compliance with global regulatory guidelines for biomarker data generation, reporting, and submissions, when applicable.
- Evaluate, recommend, and help defend the adoption of emerging technologies and innovative approaches to enable biomarker measurement in biological matrices for clinical trials.
Requirements
- PhD or MS with a minimum of 5 years of relevant experience in clinical research or clinical trial execution within immunology/nephrology.
- Demonstrated experience designing and executing biomarker and genomics research, with a proven ability to analyze, interpret, and translate data to support drug development and inform clinical trial design.
- Strong expertise across a broad range of biochemical, molecular, and cellular assay platforms, as well as bioinformatics approaches, including RNA-Seq, exome and whole genome sequencing, high-throughput proteomics, and multiplex flow cytometry.
- Working knowledge of digital biomarker applications and their integration into clinical development programs.
- Experience managing external vendors, including oversight of timelines, deliverables, contractual obligations, and regulatory compliance.
- Proven ability to manage and contribute to multiple programs at different stages of development, effectively prioritizing work in a fast-paced environment with evolving timelines.
- Demonstrated ability to translate insights from scientific literature into the design, execution, and interpretation of complex experiments and research strategies.
- Excellent verbal and written communication skills, with the ability to clearly present complex scientific concepts and data to diverse cross-functional audiences.
Qualifications
- Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity.
Skills
- Expertise in immunology and nephology.
- Strong background in clinical translational research.
- Proficiency in data analysis, visualization, and interpretation.
- Experience with a variety of biochemical, molecular, and cellular assay platforms.
- Knowledge of digital biomarker applications.
- Ability to manage external vendors and oversee timelines, deliverables, and regulatory compliance.
- Strong communication and presentation skills.
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.
- Paid leave programs.
Pay
$169,222.00 - $253,000.00, plus incentive opportunity.
Schedule
Full-time.