Jobs
View more job listings or post a job
Bioduro-Sundia Associate Director/Director in Laboratory Animal and Exploratory Toxicology
Variant Bio (Senior) Scientist - DMPK
Alturas Analytics Scientist 1
University of California, Davis TOXICOLOGY ANALYTICAL CHEMIST (STAFF RESEARCH ASSOCIATE 3)
University of California, Davis CALIFORNIA ANIMAL HEALTH AND FOOD SAFETY LABORATORY - TOXICOLOGY LAB RESEARCH SUPERVISOR/GROUP LEADER
Eli Lilly and Company R-39973 Scientific Director ADME - Novel Modalities (Open)
FibroGen Director DMPK
Applied BioMath Technical Marketing Specialist
Horizon Therapeutics Director, Bioanalytical Sciences
Exelixis Principal Scientist - DMPK
Post a job


Position:
 Director

Employer:
Vir Biotechnology, Director - Pharmacometrics

Description:

Vir Biotechnology is seeking a Pharmacometrician responsible for leading the pharmacometrics strategy across therapeutic areas and programs, from early clinical development to market application and commercialization.

  • The candidate will join the Clinical Pharmacology department reporting to the VP of Clinical Pharmacology.
  • Develops and implements model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with Project Lead Clinical Pharmacologist.
  • Responsible for pharmacometrics activities (population pharmacokinetics modeling and simulations, PK/PD, exposure-response, etc) working in close collaboration with the Project Lead Clinical Pharmacologist.
  • Conduct modeling and simulations activities for programs across various stages of development (pre-IND through post-marketing).
  • Present modeling and simulation data, acting as a technical pharmacometrics expert on cross-functional project sub-team.
  • Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety.
  • Help in providing support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.


Qualifications/Experience:
  • Ph.D. or equivalent degree with at least 10 years of experience OR MS or equivalent degree with at least 13 years of experience.
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics.
  • Understanding and ability to guide quantitative/modeling efforts. Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix, etc.) for protein therapeutics (mAbs, siRNA, etc) and small molecule therapeutics.
  • Ability to influence MIDD (model informed drug development) regulatory strategies in conjunction with the clinical pharmacology project lead.
  • Strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author and defend pharmacometrics components of regulatory filings.
  • Interact with and/or lead modeling/simulations activities with external CROs.
  • Mentor and coach junior staff within Clinical Pharmacology.


Location: REMOTE

Contact: https://boards.greenhouse.io/virbiotechnologyinc/jobs/4090268005

Post Date: 9/23/2022 12:00:00 AM
©Pharmaceutical & BioScience Society, International; Last Modified: 4/25/2024; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Lena Biosciences Predictive toxicology. Mitochondrial toxicity in a drug metabolism-competent model with active transporters. Intrinsic & idiosyncratic DILI.
Alturas Analytics, Inc. Expert Regulated & Non-Regulated LC-MS, GC-MS bioanalytical & PK/TK analysis of small & large molecules in any matrix. Discovery through phase IV.
Hypha Discovery Synthesis, purification & NMR characterization of phase I and II drug metabolites & API impurities at mg-g scale with COAs.
Lena Biosciences Predictive toxicology. Intrinsic & idiosyncratic drug-induced liver injury. Mitochondrial toxicity in a drug metabolism-competent model.
Submit a Text Ad