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, Pharmacometrics, Biomedical Engineering, Computational Biology, or related field
• 10+ years of industry with relevant pharmaceutical development experience
• Independent scientist with a strong background in ADME and/or clinical pharmacology
• 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 in a scientific or clinical setting supporting drug development.
• Experience with AAV therapeutics development is strongly preferred

Skills:

• Successfully demonstrated ability to conduct research with solid attention to detail and rigorously analyze and interpret PK/PD, biomarker, and immunogenicity data
• Sound knowledge of DMPK and PK/PD analysis principles; experience in PK/PD modeling and simulation is highly desirable
• Proficiency in standard pharmacometrics software, such as Phoenix WinNonlin/NLME, NONMEM, Watson, MONOLIX, WinBUGS, STAN, or Matlab, R or S+.
• Working knowledge of FDA, EMA, and ICH guidances relevant to 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, and Adobe Photoshop).

Base salary compensation range: $162,000 - $210,000

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