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Senior Scientist

External
4dmoleculartherapeutics logo4dmoleculartherapeutics · Emeryville, CA
Full-timeOn-site2mo ago30+ days old, may be filled
ComplianceData AnalysisLeadershipSAFe
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Benefits

Health insuranceRemote work optionsFlexible schedule

Additional Information

Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery 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 prac


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