GENERAL SUMMARY: 

This role is in the Biomarkers & Immunology department and supports immunogenicity risk assessments, biomarker measurements, and clinical pharmacology deliverables by developing novel bioanalytical methods and providing expert analysis and interpretation of key bioanalytical datasets. Bioanalytical methods are rigorously qualified and validated to generate high-quality data for internal stakeholders. Working closely with cross-functional teams (e.g., Early-Stage Product Development, Project Management, Clinical Operations, and Clinical Development), these deliverables inform key program decisions.

This position reports to the Director, Biomarkers & Immunology, and supports 4DMT’s mission and portfolio of targeted genetic medicines. On-site work is required for laboratory activities; however, a flexible hybrid schedule may be accommodated for data analysis and remote oversight of partner organizations.

MAJOR DUTIES & RESPONSIBILITIES:

• Provide scientific and technical leadership in the development and qualification of innovative bioanalytical assays, including ligand-binding assays, anti-drug antibody (ADA) assays, cell-based assays, and molecular assays to evaluate immunogenicity, PK/PD, and biomarkers for preclinical and clinical use across multiple therapeutic areas (e.g., ophthalmology, pulmonology, CNS).
• Lead assay lifecycle activities (method development, qualification, validation, and implementation), including defining fit-for-purpose performance criteria, identifying risks, and driving timely resolution of technical issues.
• Oversee GxP workflows and apply relevant regulatory guidance for early-stage and late-stage assay development, validation, and implementation. Ensure data integrity and inspection readiness as applicable.
• Independently design and execute experiments; analyze and interpret data; and communicate conclusions, limitations, and recommendations to management and study teams to enable decisions.
• Contribute to the design and interpretation of in vivo and in vitro studies to support assay development and biomarker strategy, including selection of appropriate readouts and defining decision criteria.
• Assess and select contract research organizations (CROs), lead technology transfer, and manage external assay method development, qualification, and GxP validation, including vendor performance, issue escalation, and corrective actions.
• Partner with Clinical Development and Clinical Operations to define bioanalytical strategy (including sampling strategy and assay performance characteristics) that supports key clinical pharmacology questions (PK/PD, exposure–response, dose selection).
• Review and interpret bioanalytical datasets for quality, trends, and consistency; summarize findings for study teams and contribute to data summaries.
• Author and/or review sections of clinical and regulatory documents (e.g., protocols, sample handling instructions, bioanalytical plans, study reports, Investigator’s Brochure, IND/CTA content) related to PK/PD, immunogenicity, and bioanalytical methods, ensuring scientific accuracy and consistency of key messages.
• Mentor junior staff by providing technical guidance, coaching on experimental design and data interpretation, and reviewing draft deliverables.
• Maintain awareness of relevant scientific literature and emerging technologies; recommend and pilot improvements that increase assay robustness, throughput, or interpretability.
• Write study reports and manuscripts and present results at scientific meetings.
• Maintain compliance with company Environmental Health and Safety policies, procedures, and practices.
• Contribute to a culture of continuous improvement and innovation; encourage team members to expand technical skills and deepen gene therapy expertise.

QUALIFICATIONS:

Education:

• Degree in immunology, bioengineering, molecular biology, cell biology, pharmacology, biochemistry, or a related field.
• PhD with 3+ years of industry or relevant academic experience; Master’s degree with 5+ years; Bachelor’s degree with 7+ years.

Experience:

• Bioanalytical and/or biomarker assay development experience is strongly preferred.
• Experience leading anti-drug antibody assay development and qualification and contributing to validation in a regulated environment (e.g., GxP, as applicable), including defining fit-for-purpose criteria, ensuring data integrity, and troubleshooting complex technical issues. Experience with PCR, qPCR, and droplet digital PCR; RNA-seq; and tissue culture of primary cells and established cell lines. Familiarity with ligand binding assays and LC-MS is a plus.
• Late-stage clinical trial experience, biologics license application experience, and CRO oversight (including deliverable review, issue escalation, and corrective actions) are a plus.
• Working knowledge of clinical pharmacology concepts (PK/PD, exposure metrics, dose selection, exposure–response) and experience translating study objectives into bioanalytical strategy (e.g., sampling strategy, assay performance characteristics), data generation plans, and interpretation for biologics and/or gene therapies is preferred.

Other Qualifications/Skills:

• Competence in standard microplate reader use (e.g., SoftMax software), Meso Scale Discovery platform instruments, PCR primer/probe design, and protein labeling, detection, and purification techniques.
• Demonstrated ability to independently design, develop, and execute new assay methods and to provide technical leadership through critical review of experimental plans, data quality, and conclusions.
• Strong attention to detail with the ability to rigorously analyze and interpret data, ensure data integrity and inspection-ready documentation as applicable.
• Demonstrated ability to influence cross-functional decisions by identifying bioanalytical risks, proposing mitigation plans, and aligning stakeholders on fit-for-purpose approaches.
• Ability to work cooperatively in a team-based environment, supportive of multiple viewpoints and approaches, and able to provide constructive scientific feedback.
• Strong written and verbal communication skills, with demonstrated ability to frame complex data into clear recommendations for diverse audiences (e.g., study teams, functional leaders, and external partners).
• Ability to translate assay performance (e.g., sensitivity, selectivity, drug tolerance, stability, dilutional linearity) into fit-for-purpose guidance for clinical and nonclinical analyses.
• Familiarity with data workflows and common analysis/reporting tools used to summarize and trend bioanalytical results (e.g., Excel, JMP, GraphPad Prism; Python and/or R is a plus).

Travel: <5%

Physical Requirements and Working Conditions:

• Ability to lift up to 20 lbs; bend and twist; and wear personal protective equipment (PPE) such as a lab coat, goggles/glasses, and nitrile gloves.

Base salary compensation range:$164,000 -182,000