Associate Director – Translational Research and Biomarkers

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a key translational biomarker representative within cross-functional asset teams that support clinical development initiatives.

• Design and implement biomarker strategies, encompassing target engagement/pharmacodynamic biomarkers, approaches for patient stratification, and hypotheses regarding mechanisms of action.

• Facilitate the selection of indications and patient populations by synthesizing translational and clinical biomarker data.

• Identify, select, and supervise biomarker assays within biological matrices.

• Manage outsourced functions and coordinate with external laboratory partners.

• Create biomarker analysis plans and assist in the generation, review, and interpretation of clinical biomarker data for both interim and final study analyses.

• Collaborate with both internal and external stakeholders to ensure timely delivery of biomarker activities that meet scientific, operational, and quality standards.

• Contribute to clinical study documentation related to biomarkers, regulatory submissions, and responses to inquiries from health authorities.

• Assess and adopt emerging technologies, digital biomarkers, and innovative assay platforms.

• Present biomarker strategies, findings, and recommendations to project teams and governance committees.

• Partner with Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams to enhance translational strategies and guide clinical development decisions.

⛳️ Requirements

• PhD or MS in Immunology, Neuroscience, Molecular Biology, Genomics, Pharmacology, or a related scientific field.

• At least 5 years of pertinent experience in translational medicine, biomarker sciences, clinical research, or clinical development, particularly in immunology and/or neurology.

• Comprehensive knowledge of biomarker discovery, validation, and application within clinical drug development.

• Proficiency in biochemical, molecular, cellular, and genomic technologies, including RNA-Seq, exome and whole genome sequencing, proteomics, multiplex flow cytometry, and related analytical methods.

• Experience with bioinformatics tools and the interpretation of complex multi-omics datasets.

• Familiarity with digital biomarker technologies and their potential uses in clinical development.

• Understanding of global clinical research regulations, GCP principles, and biomarker-related regulatory considerations.

• Capability to manage multiple priorities and function effectively in a dynamic, matrixed environment.

• Strong scientific problem-solving, critical thinking, and data interpretation abilities.

• Exceptional verbal and written communication skills, capable of conveying complex scientific concepts to both technical and non-technical audiences.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Assistance with student loans.

• Generous 401(k) matching program.

• Flexible time off policy.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Opportunity for incentives.