Clinical Pharmacology Associate Director

Job Summary

Responsible for overseeing all aspects of clinical pharmacology for candidate drug products from early to late-stage development, the full-time remote Clinical Pharmacology Associate Director will manage study protocols, generate hypotheses, and provide scientific leadership while collaborating with cross-functional teams.

Key responsibilities

• Design and direct nonclinical PK and clinical pharmacology studies, contributing to clinical pharmacology and research plans
• Independently write nonclinical PK and clinical PK sections in study reports and lead authoring of regulatory documents
• Serve as a resource for nonclinical pharmacokinetics/toxicokinetics and clinical pharmacology, maintaining knowledge of scientific and regulatory practices

Required qualifications

• Bachelor's/Master's degree in a scientific discipline; PhD in pharmacokinetics, pharmacology, or related field preferred
• Pharm D. or PhD with 5+ years of relevant experience; MS with 8+ years of experience in a related field
• Direct experience in creating regulatory submissions and interacting with regulatory authorities
• Proficiency with specialized software for pharmacokinetic data analysis and statistical software
• Understanding of the autoimmune therapeutic area and biologics is highly desired