Senior Scientist
4D Molecular Therapeutics
4 hours ago
Remote friendly (Emeryville, CA)
United States
Clinical Research and Development
Major Duties & Responsibilities:
- Provide scientific and technical leadership in developing and qualifying bioanalytical assays (ligand-binding, anti-drug antibody (ADA), cell-based, and molecular assays) to evaluate immunogenicity, PK/PD, and biomarkers across therapeutic areas.
- Lead the assay lifecycle (method development, qualification, validation, and implementation), including defining fit-for-purpose performance criteria, identifying risks, and resolving technical issues.
- Oversee GxP workflows and apply relevant regulatory guidance for assay development, validation, and implementation; ensure data integrity and inspection readiness as applicable.
- Independently design and execute experiments; analyze and interpret data; communicate conclusions, limitations, and recommendations to management and study teams.
- Contribute to the design/interpretation of in vivo and in vitro studies to support assay development and biomarker strategy.
- Assess/select CROs; lead technology transfer; manage external assay development, qualification, and GxP validation, including vendor performance, issue escalation, and corrective actions.
- Partner with Clinical Development and Clinical Operations to define bioanalytical strategy (sampling strategy and assay performance characteristics) for PK/PD, exposure–response, and dose selection.
- Review/interpret bioanalytical datasets and summarize findings for study teams.
- Author/review sections of clinical and regulatory documents (protocols, sample handling instructions, bioanalytical plans, study reports, Investigator’s Brochure, IND/CTA) related to PK/PD, immunogenicity, and methods.
- Mentor junior staff; provide technical guidance and review deliverables.
- Maintain compliance with Environmental Health & Safety policies.
- Write study reports/manuscripts and present results at scientific meetings.
Qualifications:
- Degree in immunology, bioengineering, molecular biology, cell biology, pharmacology, biochemistry, or related field.
- PhD with 3+ years industry/relevant academic experience; Master’s with 5+ years; Bachelor’s with 7+ years.
Preferred Skills/Experience:
- Bioanalytical and/or biomarker assay development.
- Experience leading ADA assay development/qualification and validation in a regulated environment (e.g., GxP); PCR, qPCR, droplet digital PCR; RNA-seq; tissue culture of primary and established cell lines; ligand binding assays and LC-MS are a plus.
- Late-stage clinical trial and biologics license application experience; CRO oversight (deliverable review, issue escalation, corrective actions).
- Clinical pharmacology knowledge (PK/PD, exposure metrics, dose selection, exposure–response) and ability to translate study objectives into bioanalytical strategy.
- Technical proficiency: microplate readers (e.g., SoftMax), Meso Scale Discovery instruments, PCR primer/probe design, protein labeling/detection/purification.
- Data integrity/inspection-ready documentation; strong communication and cross-functional influence.
Working Conditions:
- Travel <5%; on-site work required for laboratory activities; flexible hybrid may be possible for data analysis/remote oversight.
- Ability to lift up to 20 lbs and wear PPE (lab coat, goggles/glasses, nitrile gloves).
- Provide scientific and technical leadership in developing and qualifying bioanalytical assays (ligand-binding, anti-drug antibody (ADA), cell-based, and molecular assays) to evaluate immunogenicity, PK/PD, and biomarkers across therapeutic areas.
- Lead the assay lifecycle (method development, qualification, validation, and implementation), including defining fit-for-purpose performance criteria, identifying risks, and resolving technical issues.
- Oversee GxP workflows and apply relevant regulatory guidance for assay development, validation, and implementation; ensure data integrity and inspection readiness as applicable.
- Independently design and execute experiments; analyze and interpret data; communicate conclusions, limitations, and recommendations to management and study teams.
- Contribute to the design/interpretation of in vivo and in vitro studies to support assay development and biomarker strategy.
- Assess/select CROs; lead technology transfer; manage external assay development, qualification, and GxP validation, including vendor performance, issue escalation, and corrective actions.
- Partner with Clinical Development and Clinical Operations to define bioanalytical strategy (sampling strategy and assay performance characteristics) for PK/PD, exposure–response, and dose selection.
- Review/interpret bioanalytical datasets and summarize findings for study teams.
- Author/review sections of clinical and regulatory documents (protocols, sample handling instructions, bioanalytical plans, study reports, Investigator’s Brochure, IND/CTA) related to PK/PD, immunogenicity, and methods.
- Mentor junior staff; provide technical guidance and review deliverables.
- Maintain compliance with Environmental Health & Safety policies.
- Write study reports/manuscripts and present results at scientific meetings.
Qualifications:
- Degree in immunology, bioengineering, molecular biology, cell biology, pharmacology, biochemistry, or related field.
- PhD with 3+ years industry/relevant academic experience; Master’s with 5+ years; Bachelor’s with 7+ years.
Preferred Skills/Experience:
- Bioanalytical and/or biomarker assay development.
- Experience leading ADA assay development/qualification and validation in a regulated environment (e.g., GxP); PCR, qPCR, droplet digital PCR; RNA-seq; tissue culture of primary and established cell lines; ligand binding assays and LC-MS are a plus.
- Late-stage clinical trial and biologics license application experience; CRO oversight (deliverable review, issue escalation, corrective actions).
- Clinical pharmacology knowledge (PK/PD, exposure metrics, dose selection, exposure–response) and ability to translate study objectives into bioanalytical strategy.
- Technical proficiency: microplate readers (e.g., SoftMax), Meso Scale Discovery instruments, PCR primer/probe design, protein labeling/detection/purification.
- Data integrity/inspection-ready documentation; strong communication and cross-functional influence.
Working Conditions:
- Travel <5%; on-site work required for laboratory activities; flexible hybrid may be possible for data analysis/remote oversight.
- Ability to lift up to 20 lbs and wear PPE (lab coat, goggles/glasses, nitrile gloves).