Director of Clinical Pharmacology

The Fountain Group is currently seeking a Clinical Pharmacologist for a prominent client of ours. This position is 100% REMOTE. Details for the position are as follows:

Job Description:

• Overview:
  • 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:

• PhD
• 12+ years relevant pharma or biotech industry experience
• 8+ years within biologics or large molecule modalities
• Strong PK/PD pharmacology background
• Pharmacometrics
• PK/PD data analyses: non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities as needed.
• Experience with regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings
• NDA / BLA submission

Compensation: Up to $310 per hour