Overview
Remote
$280 - $300
Contract - W2
Contract - 06 Month(s)
No Travel Required
Skills
Pharmacology
Pharmaceutics
CLINICAL
Job Details
Job Title: Clinical Pharmacologist Job ID: 25-07547 Location: 100% REMOTE Duration: 06 months on W2 Contract
Description:
Director, Clinical Pharmacology
Virtual(via Kendall Square, Cambridge, MA)
This contractor will serve as a back up to the internal FTE on projects.
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 knowledge.
This contractor will serve as a back up to the internal FTE on projects.
This individual will support the clinical pharmacology strategies and PK/PD aspects of clinical studies (from protocol to CSR) as well as related regulatory submission activities. This role requires a strong clinical pharmacology experience and pharmacokinetics/pharmacodynamics/pharmacometrics knowledge.
Job Responsibilities
Description:
Director, Clinical Pharmacology
Virtual(via Kendall Square, Cambridge, MA)
This contractor will serve as a back up to the internal FTE on projects.
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 knowledge.
This contractor will serve as a back up to the internal FTE on projects.
This individual will support the clinical pharmacology strategies and PK/PD aspects of clinical studies (from protocol to CSR) as well as related regulatory submission activities. This role requires a strong clinical pharmacology experience and pharmacokinetics/pharmacodynamics/pharmacometrics knowledge.
Job Responsibilities
- Act as the Clinical Pharmacology Lead on early- to late-stage programs to set clinical development plans.
- 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 regulatory filings.
Qualifications
Minimum Education Requirement
Minimum Education Requirement
- A Ph.D. or equivalent degree in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics or a related field.
Required Experience and Skills
- At least 12 years of full-time experience in a clinical pharmacology role within the pharmaceutical or biotechnology industry. Candidates with substantial expertise working directly in industry settings, rather than consulting or contracting roles, are preferred.
- A minimum of 8 years of direct experience working on large molecule therapeutic modalities or biologics.
- Demonstrated success in leading NDA and/or BLA submissions, showcasing a strong track record of regulatory accomplishments.
- Exceptional verbal and written communication skills, combined with keen attention to detail and organizational proficiency.
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