Clinical Pharmacology Consultant

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Clinical Pharmacology Consultant based in the United States. We are seeking an experienced Clinical Pharmacology Consultant to support the development of innovative therapies for patients with rare and inherited diseases. In this remote contract role, you will bring specialized expertise in clinical pharmacology to clinical-stage drug development programs, helping translate complex scientific data into meaningful insights that inform clinical and regulatory decisions. You will play a key role in study design, pharmacokinetic and pharmacodynamic data analysis, and the preparation of clinical and regulatory documentation. Working closely with multidisciplinary teams, you will contribute to advancing development programs from early clinical exploration through later-stage studies. This opportunity is ideal for a scientifically rigorous professional who enjoys solving complex problems, collaborating across functions, and making a tangible contribution to the development of potentially life-changing medicines.

Provide clinical pharmacology expertise and input for regulatory submissions and other development documentation. Contribute to clinical study design and the preparation and review of study documents, including laboratory manuals, clinical protocols, and statistical analysis plans (SAPs). Independently lead and oversee the analysis, interpretation, integration, and reporting of clinical pharmacokinetic (PK) and pharmacodynamic (PD) data for assigned projects. Collaborate with cross-functional stakeholders across Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory Affairs to support project milestones and broader organizational objectives. Oversee work performed by contract research organizations (CROs) and external vendors, ensuring alignment with approved protocols, quality standards, and project timelines. Apply scientific judgment and analytical expertise to help guide clinical development decisions and strengthen the evidence supporting investigational therapies. Requirements: Master’s degree with at least 8 years of relevant experience, Ph.D. with at least 3 years of relevant experience, or Pharm.D. or M.D. with applicable experience in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or a related discipline. Demonstrated experience in clinical pharmacology and clinical study design within the biotechnology or pharmaceutical industry. Strong understanding of clinical PK/PD data analysis, interpretation, integration, and reporting. Experience with pharmacokinetic analysis and modeling software, such as Phoenix WinNonlin, R, NONMEM, MATLAB, or comparable tools. Strong mathematical modeling, quantitative analysis, problem-solving, and scientific communication skills. Experience spanning early exploratory clinical trials through Phase 2 or Phase 3 programs is preferred, along with a relevant publication record. Experience with compartmental PK/PD modeling is an advantage. Ability to work independently, manage assigned project responsibilities, and collaborate effectively with multidisciplinary teams and external partners. A curious, creative, and persistent approach to scientific challenges, with a strong commitment to collaboration and patient-focused drug development. Benefits: Remote flexibility: Work remotely from within the United States. Contract engagement: A flexible consulting opportunity offering approximately 30–40 hours per week. Scientific impact: Contribute to clinical-stage development programs targeting rare and inherited diseases. Cross-functional collaboration: Partner with experts across clinical development, biostatistics, non-clinical development, clinical operations, and regulatory functions. Professional contribution: Apply advanced clinical pharmacology and quantitative modeling expertise to support evidence-based development decisions. Compensation and additional benefits: Salary or hourly rate, healthcare coverage, paid time off, and other benefits were not specified in the original posting.