Job Description

We are seeking an experienced Clinical Pharmacology Consultant to advise on subcutaneous (SC) versus intravenous (IV) dosing strategy, pharmacokinetics/pharmacodynamics (PK/PD), bioavailability interpretation, and regulatory justification for upcoming interactions with the FDA.

This is a part-time consulting role, approximately 5–7 hours/week for a few months and is strictly advisory, with no formulation or clinical operations responsibilities.

Responsibilities

• Review and interpret PK/PD and bioavailability data comparing SC and IV administration
• Assess SC bioavailability performance (poor, moderate, or good) based on available datasets
• Determine the appropriate SC dose using PK analyses, relative exposure, and IV–SC comparisons
• Develop a clear scientific and regulatory rationale to support SC dose selection
• Advise on data gaps, next steps, and overall readiness for FDA engagement
• Support preparation for FDA discussions, ensuring the dose-selection justification is clear, defensible, and aligned with expectations
• Provide expert guidance on bioavailability implications without performing formulation development

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

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled