Clinical Pharmacology Consultant
Remote · United States
United StatesRemoteContractMid LevelDoctorate Or Professional DegreeUnknown
Type
Contract
Level
Mid Level
Education
Doctorate Or Professional Degree
Company size
Unknown
Job Summary
Clinical Pharmacology Consultant providing expert advisory on SC vs IV dosing, PK/PD interpretation, bioavailability assessment, and regulatory justification for FDA interactions. Role focuses on dose-selection rationale, data gaps, and readiness for FDA discussions; no formulation or clinical operations responsibilities. Part-time, ~5–7 hours/week for several months, with strong emphasis on translating PK findings into regulatory arguments for FDA clearance.
Required Qualifications
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, or related discipline
- Equivalent advanced training or significant industry experience may be considered for exceptional candidates
- Direct experience selecting SC doses from IV data, presenting justification to the FDA, and obtaining FDA clearance
- Strong background in clinical pharmacology, PK/PD, and dose–exposure relationships
- Deep understanding of SC drug delivery and absorption variability
- Ability to assess relative bioavailability and interpret complex PK datasets
- Experience developing dose-selection strategies when transitioning a product from IV to SC administration
- Familiarity with FDA expectations for PK justification, exposure bridging, and regulatory rationale
- Experience with hyaluronidase-enabled SC delivery preferred
- Ability to provide concise strategic recommendations based on limited datasets
- Strong communication skills, especially in translating PK findings into clear regulatory arguments
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