Clinical Pharmacologist/part time
Company: LanceSoft, Inc.
Posted on: January 13, 2022
Title: Clinical PharmacologistDuration: 5 monthsLocation:
Cambridge, MA 02142
100% REMOTE10 hours per week (with flexibility to increase as
needed)Timings: 08 AM to 11 AM This contractor will serve as a back
up to the internal FTE on projects. Job Description:This individual
will support the PK/PD aspects of clinical studies (from protocol
to CSR) and related regulatory submission activities. This role
requires a strong pharmacokinetics/pharmacodynamics/pharmacometrics
- Support PK/PD aspects of clinical studies, including
synopsis/protocol development, statistical analysis plan and
clinical pharmacology data analysis plan review, TLF shell and
dry-run reviews, and CSR.
- Oversee relevant PK/PD data analyses: non-compartmental PK,
population PK and PK/PD, and other modeling and simulation
activities as needed.
- Contribute to regulatory documents including Investigator
Brochures, Labeling and those required for regulatory meetings and
Qualifications:Minimum Education Requirement
- A Ph.D. or equivalent degree with at least 5 years of
experience OR an MS or equivalent degree with at least 10 years of
experience, where experience means having a proven track record
within the duties mentioned above in pharmaceutical industry,
regulatory agency, or academia.
Required Experience and Skills:
- Educational background in clinical pharmacology,
biopharmaceutics, pharmaceutical sciences, biomedical engineering,
statistics or a related field.
Excellent verbal and written communication skillsDetail-oriented
Keywords: LanceSoft, Inc., Cambridge , Clinical Pharmacologist/part time, Healthcare , Cambridge, Massachusetts
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