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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
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