- Develop and apply QSP and pharmacokinetic models to programs for novel gene editor modalities and disease modeling platforms at Verve.
- Independently analyze, interpret, and report PK, PK/PD, and QSP modeling results for internal decision making and regulatory filings.
- Develop modeling and simulation strategies for interpretation and design of preclinical studies, and mechanistic projection of pharmacodynamic data in varied patient populations.
- Support the clinical pharmacology, and clinical development groups at Verve to implement back-translation of early clinical exposure and pharmacodynamic data.
- Work closely with Verve pharmacologists, toxicologists, and bioanalytical team to help design in vivo studies and in vitro studies to characterize gene editing therapies.
- Maintain visibility of QSP and pharmacometrics functions internally and externally through publications, and presentations and mentoring non-modeler scientists.
- Other duties as assigned.
- Ph.D. (or equivalent) degree with a focus in quantitative systems pharmacology, mathematical modeling, or related disciplines.
- At least 5 years' relevant experience in the pharmaceutical/biotech industry, including at least 2 years of exposure to concepts of quantitative systems pharmacology and pharmacometrics.
- A thorough understanding of quantitative systems pharmacology, pharmacometrics principles including familiarity with pharmacology/safety aspects of drug discovery and development.
- Direct experience with modeling tools such as MATLAB/Simbiology, WinNonLin.
- Experience with coding using the R/Python or similar languages.
- Ability to collaborate and influence at all levels across an organization.
- Exceptional written and verbal communication allowing oneself to communicate scientific data and information to others in a digestible format.
- Analytical mindset and good problem-solving ability.
- Demonstrated ability to critically evaluate and contribute to multiple scientific programs.
- Diligence and attention to detail.
- Good organizational skills.
- Track record of regulatory interactions, including authoring of regulatory documents and responding to and resolving regulatory requests for information.
- Command of current literature in quantitative systems pharmacology with recent contributions including publications and conference presentations.
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Senior Scientist, Quantitative Systems Pharmacology - Boston, United States - Verve Therapeutics, Inc.
Description
Job Description
Job DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.
The PositionVerve is seeking an experienced modeling senior scientist to join our team as we continue to advance gene editing medicines for cardiovascular disease into clinical development. The successful applicant will develop fit-for-purpose, quantitative systems pharmacology (QSP) models and support pharmacometric modeling across key gene editing programs. The modeler will collaborate closely with scientists across the non-clinical (in vivo pharmacology, bioanalysis, and toxicology) and clinical teams to provide feedback on interpretation of experimental data and on study design to advance the understanding of gene editing drugs. In addition, and in collaboration with expert consultants, they will analyze data obtained from trial participants treated with Verve gene editing products. The individual will help develop the overall strategy for quantitative systems pharmacology and support effective communication with health authorities.
Job ResponsibilitiesThe targeted salary range for this position is $145,000 - $175,000 per year. Verve is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Verve's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
EEO StatementVerve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & Staffing AgenciesVerve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.