logo inner

Director, Immunogenicity & Biomarkers

4D Molecular TherapeuticsEmeryville, California, United StatesOnsite
This job is no longer open

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 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.  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 medicineGENERAL 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:

  • Representing Biomarkers & Immunology function on cross-functional teams 
  • 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 experience4DMT 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.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This job is no longer open

Life at 4D Molecular Therapeutics

The mission of 4D Molecular Therapeutics is to design and develop transformative gene therapy products using our proprietary technology to create novel adeno-associated virus variants to be utilized as treatments for serious unmet medical conditions. Our products are unlocking the full potential of gene therapy to treat, and potentially cure, genetic diseases. A large number of patients and diseases, who previously were not treatable by gene therapy, will be addressable by 4D products. 4D has one of the deepest and most diverse product pipelines in the gene therapy field. Adeno-associated virus (AAV) vectors have emerged as a favored delivery vehicle for gene therapy in the human body. They can deliver the genes for therapeutic proteins to accessible tissues in the body and are generally considered safe. Several AAV gene therapy products are in late-stage clinical development, and one product is approved in the EU (Glybera, Uniqure). However, these first-generation AAV vectors have limited utility for the majority of diseases. Many of these common AAV were discovered as laboratory contaminants and monkey infections, for example; they have not been customized as targeted medicines. In contrast, 4D customized AAV vectors, and the products made from them, are designed to unlock the full potential of gene therapy. Through 4D's Therapeutic Vector Evolution, we are able to create customized vectors solutions to overcome the hurdles identified with first-generation AAV vectors. 4D is creating the ultimate gene therapy products to cure genetic diseases using new customized delivery vehicles (vectors) to shuttle genes into the cells in any organ in the body. This 4D library of vectors will soon include several for the liver, several for the brain, several for the heart, the eye, muscle, and so on. Doctors will be able to hand pick a vector for any patient based on the organ that is diseased.
Thrive Here & What We Value1. Collaborative and innovative work environment2. Emphasis on scientific excellence and innovation3. Focus on patient outcomes and improving lives through genetic medicine4. Opportunities for career growth and professional development5. Commitment to diversity, equity, and inclusion6. Robust technology and IP foundation, including TVE and manufacturing platforms7. Initial product safety and efficacy data substantiates platform value8. Rapid progression from idea to IND9. Expanding opportunities in genetic medicine indications and modalities10. Internal manufacturing capabilities
Your tracker settings

We use cookies and similar methods to recognize visitors and remember their preferences. We also use them to measure ad campaign effectiveness, target ads and analyze site traffic. To learn more about these methods, including how to disable them, view our Cookie Policy or Privacy Policy.

By tapping `Accept`, you consent to the use of these methods by us and third parties. You can always change your tracker preferences by visiting our Cookie Policy.

logo innerThatStartupJob
Discover the best startup and their job positions, all in one place.
Copyright © 2024