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Posted 3 months ago
Requirements and responsibilities
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.
Optionally, you can add more information later (benefits, pre-screening questions, etc.)