Principal Scientist, Immunogenicity
4D Molecular Therapeutics
At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL ROLE DESCRIPTION:
This role will be in the Immunology & Bioanalytical Sciences group. The group supports immunogenicity risk assessments, pharmacokinetic evaluations, biomarker measurements, and exploratory immunology research by developing novel bioanalytical methods. These methods are rigorously qualified and validated to characterize their performance and ensure that high-quality data are delivered to our internal stakeholders. Working closely with multiple groups, such as Technology Innovation, Biomarkers, Project Management, Clinical Sciences, and Pharmtox, on cross-functional teams, we help determine the impact of our deliverables on important program decisions.
This role will report to the Senior Director of Immunology & Bioanalytical Sciences and be part of a talented, motivated, and creative team of scientists who are critical for the success of 4DMT’s mission and development of our deep portfolio of targeted genetic medicines. While on-site presence is required to perform laboratory work, a flexible hybrid work schedule can be accommodated when analyzing data and remotely managing partner organizations.
- Developing and designing cutting edge, innovative bioanalytical assays for preclinical and clinical use in multiple therapeutics areas, e.g. ophthalmology, pulmonology, CNS, etc., through individual expertise and scientific teamwork
- General areas of assay development will be in ligand-binding assays, cell-based assays and molecular assays to evaluate immunogenicity, PK, biodistribution, and biomarkers
- Designing & executing experiments, analyzing data using next-gen analytical techniques, and presenting data to line management and study teams
- Contributing to the design, implementation, and interpretation of in vivo and in vitro experimental studies
- Assessing the utility and selection of contract research organizations (CROs), managing technology transfer, overseeing assay method development, qualification and validation
- Providing oversight of study samples, analysis plans, and testing schedule for CRO
- Performing hands-on experiments and innovative research in the company’s lab to develop in house bioanalytical methods and analyze research study samples
- Potential for contribution to analytical development bioassays
- Leveraging a strong understanding of bioanalytical assays, assess and interpret experimental data, then using the resulting information to inform product development
- Effectively mentoring junior level staff and acting as a resource for scientific expertise
- Utilizing appropriate scientific approaches to understand characteristics of gene expression and protein function to drive decisions and assess potential application of company’s lead adeno-associated virus vectors and products
- Maintaining current awareness of scientific literature
- Actively applying new concepts and technologies
- Leading and supporting research initiatives such as new technology development and platform improvement projects
- Writing study reports and manuscripts and presenting results at scientific meetings
- Maintaining compliance with company Environmental Health and Safety policies, procedures, and practices
- Contributing to building a culture that embraces continuous learning, improvement, and innovation and encourages team members to expand their technical skill base and deepen their gene therapy expertise.
Education & Experience:
- Degree in Immunology, Bioengineering, Molecular Biology, Cell Biology, Pharmacology, Biochemistry or related field
- With a PhD – 8+ years of industry experience, Master’s degree with 10+, Bachelors with 12+ years
- Prior experience with bioanalytical or biomarker assay development strongly preferred
- Competence in use of standard microplate readers with SoftMax software, MesoScale Discovery platform instruments; protein labeling, detection, and purification techniques
- Experience with tissue culture of primary cells and established cell lines
- Familiarity with PCR and multicolor flow cytometry would be a plus
- Successfully demonstrated ability to work independently in designing, developing, and executing new assay methods
- Successfully demonstrated ability to conduct research with strong attention to detail and rigorously analyze and interpret data
- Ability to multi-task and support more than one project simultaneously
- Highly organized and motivated; strong analytical, organizational, and problem-solving skills
- Strong work ethic, flexibility, and cooperative can-do attitude
- Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches
- Strong communication skills (both written and oral) with demonstrated ability to present ideas, information and data effectively via one on one discussions, team meetings, and external partnership interactions
- Understanding and knowledge of key scientific software programs (including Microsoft Office, JMP or Prism, Adobe Photoshop).
Base salary compensation range:
Bay Area Range:
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.