Director, Immunogenicity & Biomarker

GENERAL ROLE DESCRIPTION:

The Director role will be within the Biomarkers & Immunology group, which is 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 report to the Senior Director of Biomarkers & Immunology 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. 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 that compensation varies depending on a variety of factors including location, experience, etc.