Associate Director, Pharmacology

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 medicine

The Associate Director, Clinical Pharmacology will be in the Biomarkers & Immunology group. The group leads pharmacokinetic (PK) evaluations, pharmacodynamic (PD) biomarker strategy, immunogenicity risk assessments, and exploratory clinical research during AAV product development. Working closely with multiple cross-functional stakeholders, such as Clinical Sciences, PharmTox, Clinical Operations, Vector Discovery, and Project Management, the group informs and influences key therapeutic product development 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. While this role may be fully remote, a hybrid or on-site work schedule can be accommodated if desired.

PRIMARY RESPONSIBILITIES:

• Leading design, execution, and analysis of PK/PD, biodistribution, metabolism, germline transmission, and shedding studies in AAV therapeutics programs
• Applying quantitative skills to support model-based drug development and address complex issues via modeling and simulation, e.g. candidate selection, dose optimization
• Analyzing data using next-gen analytical techniques, and presenting data to line management, cross-functional teams, study teams, and regulatory agencies
• Leveraging a strong understanding of bioanalytical assays to analyze and interpret PK/PD data to drive key decisions in AAV product development, e.g., FIH dose selection
• Assessing potential impact from immunogenicity of therapeutic candidates on PK, PD biomarkers, and clinical efficacy or safety endpoints
• Utilizing appropriate scientific approaches to understand characteristics of AAV vector-mediated gene expression and transgenic protein function
• Support the preparation of content for regulatory interactions and submissions (e.g. pre-IND Briefing Books, IND filings, Orphan Drug Designation, EMA submissions)
• Representing Biomarkers & Immunology function on cross-functional teams
• Collaborating with bioanalytical teams to forecast analytical requirements for projects and assess suitable method performance
• Effectively mentoring junior level staff and acting as a resource for scientific expertise
• May lead dedicated subteams responsible for analysis of PK, PD biomarkers, immunogenicity, and molecular endpoints in investigational AAV therapeutics programs
• Maintaining current awareness of scientific literature and regulatory guidance
• 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:

• PhD. in Pharmacology, Pharmaceutics, Pharmacokinetics and Metabolism, Pharmaco