Director, Immunogenicity
2 months ago
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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.
Company Differentiators:
• 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:
The Director role will be within the Biomarkers & Immunology group, part of the Development Sciences department. The group performs immunogenicity assessments, biomarker measurements, molecular assays, and exploratory clinical research during AAV therapeutics development. Our responsibilities include in-depth data analysis and interpretation as well as bioanalytical method development. Methods are then rigorously validated at CROs to characterize their performance and ensure that high-quality data are generated. Working closely with multiple cross-functional stakeholders, such as Clinical Sciences, Pharmtox, Clinical Operations, Technology Innovation, and Project Management, our data deliverables and analyses have significant impact on key program decisions.
This role will 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. A flexible hybrid work schedule can be accommodated when analyzing data, working on cross-functional teams, and remotely managing partner organizations.
PRIMARY RESPONSIBILITIES:
Devising bioanalytical portfolio strategy, immunogenicity risk assessments, and biomarker plans for investigational AAV therapeutics programs
Leading bioanalytical subteams responsible for measuring PK, biomarkers, immunogenicity, and molecular endpoints in investigational AAV therapeutics studies
Utilizing appropriate scientific approaches to understand characteristics of AAV vector-mediated gene expression and transgenic protein function
Leveraging a strong understanding of bioanalytical assays to analyze and interpret data in order to drive key decisions in AAV product development, e.g., FIH dose selection
Assessing the utility and selection of contract research organizations (CROs), managing technology transfer, overseeing method development, qualification and validation
Providing oversight of study samples, analysis plans, and testing schedules for CROs
Contributing to the design and implementation of non-clinical and clinical studies, including IND-enabling studies
Leading design, execution, and analysis of bioanalytical assessments to measure biomarkers, immunogenicity, biodistribution, germline transmission, and vector shedding
Assessing potential impact from immunogenicity of therapeutic candidates on PK/PD and clinical efficacy or safety endpoints
Designing experiments, analyzing data using next-gen analytical techniques, and presenting conclusions to line management, study teams, and regulatory agencies
Effectively mentoring junior level staff and acting as a resource for scientific expertise
Support the preparation of content for regulatory interactions and submissions (e.g. pre-IND Briefing Books, IND filings, Orphan Drug Designation, EMA submissions)
Maintaining current awareness of scientific literature and regulatory guidances
Writing and reviewing technical documents, study protocols and reports, 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 skill base and deepen their gene therapy expertise.
QUALIFICATIONS:
Education & Experience:
Ph.D. degree in Immunology, Molecular Biology, Cell Biology, Bioengineering, Pharmacology, Biochemistry, or related field
10+ years of industry experience
5+ years of People management experience
Strong scientific acumen as demonstrated by first or last author publications in peer-reviewed scientific journals and ability to work in a matrixed environment
Previous experience in cross-functional teams and work in a scientific or clinical setting supporting drug development.
Previous experience with bioanalytical method development, immunogenicity assessments, and/or biomarker development
Prior experience selecting and efficiently managing CROs
AAV gene therapy experience is preferred
Skills:
Successfully demonstrated ability to work independently in overseeing the design, development, and execution of new bioanalytical methods
Successfully demonstrated ability to conduct research with strong attention to detail and rigorously analyze and interpret PK/PD, biomarker, and immunogenicity data
Competence in using standard microplate readers, MesoScale Discovery instruments, as well as protein labeling, detection, and purification techniques
Experience with tissue culture of primary cells and established cell lines
Familiarity with qPCR and/or ddPCR methodology and multicolor flow cytometry
Working knowledge of GLP (21 CFR Part 58) and GCLP principles as they relate to bioanalytical method validation and regulated sample analysis
Working knowledge of FDA, EMA, and ICH guidance documents relevant for AAV therapeutics development, immunogenicity assessments, and bioanalytical methods
Ability to multi-task and support more than one project simultaneously
Highly organized and motivated self-starter with strong analytical and problem-solving skills
Strong work ethic, flexibility, and cooperative can-do attitude
Ability to work 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: $235,000/yr - $278,000/yr
Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
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