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Verve Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, is pioneering the development of in vivo gene editing therapies to transform the treatment of cardiovascular disease. The Clinical Pharmacology and Pharmacometrics function within Verve serves as a strategic cornerstone of R&D, integrating quantitative methods across preclinical through clinical development to inform dosing strategy, trial design, and regulatory decisions for our lipid nanoparticle (LNP)-delivered gene editing programs. Our team employs advanced modeling and simulation approaches—including physiologically based pharmacokinetics (PBPK), population PK/PD, quantitative systems pharmacology (QSP), and exposure-response analysis—to enable Model-Informed Drug Development (MIDD) across all stages from target validation to registration. Embedded within the broader Lilly Research & Development ecosystem, we offer the agility of a biotech with the resources and global reach of a leading pharmaceutical company.
**Responsibilities: **
The Director will provide scientific leadership for clinical pharmacology, pharmacometrics, and translational modeling across Verve’s cardiovascular gene editing pipeline. This role spans the full translational continuum from preclinical species modeling through clinical dose optimization and regulatory submission, serving as the quantitative pharmacology subject matter expert on cross-functional program teams.
- Lead the development and execution of comprehensive clinical pharmacology and pharmacometrics strategies for LNP-delivered gene editing therapeutics, spanning preclinical-to-clinical translation, dose selection, and regulatory filing.
- Develop and apply preclinical translational models, including PBPK and semi-mechanistic PK/PD models to predict human pharmacokinetics and inform first-in-human dose projections.
- Design and implement population pharmacokinetic and exposure-response analyses using NONMEM, STAN, nlmixr2, or Monolix to optimize Phase 2/3 dose regimens.
- Author and review clinical pharmacology sections for IND, NDA/BLA submissions and regulatory briefing documents.
- Represent the organization in interactions with global regulatory agencies (FDA, EMA, PMDA) on clinical pharmacology, translational modeling, and MIDD strategies.
- Coordinate and oversee external modeling and simulation partners and pharmacometric work to ensure prompt, high-quality deliverables.
**Basic Requirements: **
- Ph.D. in Pharmaceutical Sciences, Pharmacology, Pharmacometrics, Quantitative Pharmacology, Chemical/Biomedical Engineering, or a related quantitative field.
- Minimum of 10+ years of pharmaceutical or biotechnology industry experience in clinical pharmacology and pharmacometrics, with demonstrated scientific leadership across preclinical and clinical development.
Additional Skills/Preferences:
- Proven hands-on expertise in population PK/PD modeling using NONMEM, STAN, nlmixr2, or Monolix;
- Proficiency in R programming for data analysis, visualization, and modeling workflows; and experience with PBPK platforms for preclinical-to-clinical translation of LNP or RNA-based therapeutics.
- Regulatory Knowledge: Track record of authoring clinical pharmacology components for regulatory submissions (IND, NDA, BLA) and successful interactions with the FDA, EMA, or other global agencies. In-depth understanding of ICH guidelines, FDA guidance on MIDD, and evolving regulatory expectations for gene editing and gene therapy modalities.
- Proficient in QSP modeling platforms and PBPK tools for mechanistic modeling.
- Proven ability to lead and influence cross-functional teams in a fast-paced, highly matrixed environment bridging biotech agility and large pharma infrastructure.
- Strong track record of scientific visibility through peer-reviewed publications, invited presentations at conferences, and contributions to MIDD white papers or regulatory guidance.
- Experience with Bayesian methods, and optimal designs
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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$193,500 - $338,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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