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Principal Scientist, Pharmacology
4 months ago
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers 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.
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 Principal Scientist Pharmacology role will be in the Biomarkers & Immunology group. This role is largely responsible for setting pharmacokinetic data analysis and establishing PK parameters of investigational compounds. This individual will serve as a subject matter expert from IND enabling through BLA filing. You will establish human dose projection and evaluate the effects of immunogenicity and biomarkers on PK/PD, primarily in the clinical setting. The group performs pharmacokinetic (PK) evaluations, pharmacodynamic (PD) biomarker measurements, 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, Technology Innovation, and Project Management, our data deliverables and analyses have a 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:
Serve as Subject Matter Expert within the department for PK, FIH dose projection, and data analysis—from IND enabling and early clinical through BLA filing Will perform quantitative pharmacology and pharmacometrics analysis and activities within assigned programs to yield high-value PK/PD support for critical decisions and dose selection Will manage translational and clinical pharmacology efforts such as study design, protocol preparation, data analysis, and reporting Lead highly collaborative cross-functional subteams responsible for analysis of PK, PD biomarkers, immunogenicity, and molecular endpoints in investigational AAV therapeutics programs Utilizing appropriate scientific approaches to understand the effects of immunogenicity on PK, PD biomarkers, clinical safety, and unique challenges of AAV vector-mediated gene expression and transgenic protein function on pharmacokinetic analysis and clinical projections Leading design, execution, and analysis of PK/PD, biodistribution, metabolism, germline transmission, and shedding studies in AAV therapeutics programs Support the preparation of content for regulatory interactions and submissions 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:
Ph.D. in pharmacology, pharmaceutics, pharmacokinetics and metabolism, pharmacometrics, biomedical engineering, computational biology, or related field 5+ years of industry experience 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 or gene therapy is preferredSkills:
Successfully demonstrated ability to conduct research with strong attention to detail and rigorously analyze and interpret PK/PD data Sound knowledge of DMPK and PK/PD analysis principles; experience in PK/PD modeling and simulation is highly desirable Proficiency in common pharmacometrics software, such as Phoenix WinNonlin/NLME, NONMEM, MONOLIX, R or S+. Working knowledge of FDA, EMA, and ICH guidances 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 compensation range: $ 182,000/yr - $217,000/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. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
