Director, Clinical Pharmacology and Translational Modeling

Director, Clinical Pharmacology and Translational Modeling Employer Eli Lilly and Company Location Boston, Massachusetts Start date May 20, 2026 View more categories View less categories Discipline Clinical , Clinical Research , Science/R D , Pharmacology Required Education Doctorate/PHD/MD Position Type Full time Hotbed Genetown , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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 approachesincluding physiologically based pharmacokinetics (PBPK), population PK/PD, quantitative systems pharmacology (QSP), and exposure-response analysisto 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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. #WeAreLilly Company Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to take what you find here and make it better and better. More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. Company info Location 893 S Delaware St Indianapolis Indiana 46285 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert