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:
Senior Clinical Pharmacologist

Employer:
Horizon Therapeutics

Description:

Position Summary: Support clinical pharmacology and DMPK function from pre-IND to post approval for both small and large molecules in all therapeutic areas.

 

Responsibilities:

 

  • Support clinical pharmacology and DMPK function from pre-IND to post approval for both small and large molecules in all therapeutic areas.
  • Under the guidance of clinical pharmacology lead, collaborate with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-man studies.
  • Conduct non-compartmental and population PK, PK/PD, and exposure-response analysis to support study design and data interpretation of clinical pharmacology studies.
  • Present clinical pharmacology and DMPK results to internal and external stakeholders.
  • Contribute to author nonclinical, clinical and regulatory documents related to DMPK and clinical pharmacology components, including protocols, study reports, INDs, IBs, briefing documents for regulatory meetings, and NDA/BLA; author scientific publications.
  • Work closely with collaborators and CROs in study protocol/report review for both preclinical and clinical studies.


Qualifications/Experience:
  • >3 years of industry or equivalent experience and an MD, PhD or PharmD degree in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, clinical pharmacology or other related disciplines
  • Experience in mathematical modeling and programming (e.g. R, NONMEM, Phoenix WinNonlin) is preferred
  • Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
  • Self-directed and motivated researcher, with willingness to learn new tools and approaches.
  • Excellent written and verbal communication skills.


Location: South San Francisco, CA or remote

Contact: ysong@horizontherapeutics.com

Post Date: 10/3/2022 12:00:00 AM
©Pharmaceutical & BioScience Society, International; Last Modified: 3/29/2024; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

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.
Lena Biosciences Predictive toxicology. Mitochondrial toxicity in a drug metabolism-competent model with active transporters. Intrinsic & idiosyncratic DILI.
Submit a Text Ad