Executive Director, Clinical Pharmacology

Responsibilities

• Provide scientific leadership for clinical pharmacology strategy across programs, focusing on PK, ADA, and exposure–response relationships
• Lead the analysis, interpretation, and integration of PK and ADA data from rodent, non-human primate (NHP), and clinical studies
• Guide dose selection and optimization strategies using nonclinical–clinical translation and clinical PK/ADA data
• Interpret non-clinical PK and immunogenicity data to support first-in-human starting dose and escalation strategy
• Serve as the clinical pharmacology subject-matter expert on clinical study teams
• Support the design and interpretation of clinical PK/ADA sampling strategies
• Author and review clinical pharmacology–related sections of regulatory documents such as INDs, BLAs, CSRs, and Investigator’s brochures

Requirements

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or a related discipline (MD or PharmD with relevant experience considered)
• 12+ years of progressive experience with demonstrated program leadership
• Strong hands-on experience with clinical and non-clinical PK data interpretation
• Expertise in Immunogenicity (ADA/NAb) assessment and impact analysis
• Experience in biologic drug development, ideally in cardiovascular, rare, or inflammatory diseases
• Proven track record supporting IND-enabling through late-stage clinical development
• Experience contributing to or leading regulatory submissions and agency interactions

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Its lead product, ARCALYST®, is the first and only FDA-approved therapy for recurrent pericarditis.