Clinical Pharmacology Expert

Job Summary

Join our customer's team as a Clinical Pharmacology & Translational Science Expert and make a significant impact from early-phase to late-phase clinical development. In this pivotal remote, part-time role, you will leverage your expertise in PK/PD modeling, clinical trial design, and translational strategy to drive informed decision-making and elevate drug development programs. Your strong written and verbal communication skills will be essential for effective collaboration across global, cross-functional teams.

Key Responsibilities

Critically analyze PK/PD models, exposure–response relationships, and dose-selection strategies for clinical and translational studies. Evaluate clinical trial design, including endpoints, eligibility criteria, and operational feasibility to ensure robust and ethical studies. Interpret clinical safety and efficacy data, with a focus on therapeutic index and safety/efficacy balance. Review IND-enabling data and translate preclinical findings to clinical relevance, informing go/no-go decisions. Provide structured scientific assessments to support model training, dose escalation, and trial progression. Collaborate closely with multidisciplinary teams to review regulatory submissions and align with FDA/EMA guidelines. Communicate complex scientific concepts clearly through written reports and presentations to diverse stakeholders.

Required Skills and Qualifications

PhD in Pharmacology, Clinical Pharmacology, Pharmaceutics, or a related discipline; or MS/BS with 8+ years in clinical development or translational science. Minimum 3 years’ experience in clinical pharmacology, translational medicine, or clinical trial design. Expertise in PK/PD modeling, dose rationale, and exposure–response analysis across clinical phases I–III. Proven ability to interpret safety signals and integrate clinical and preclinical data. Familiarity with FDA/EMA clinical and regulatory guidelines. Exceptional written and verbal communication abilities, with a collaborative, detail-oriented approach.

Preferred Qualifications

Experience working in both early- and late-phase clinical drug development programs. Demonstrated success translating preclinical models into actionable clinical strategies. Track record of impactful collaboration within global project teams.