Executive Director, Clinical Development Lead

Responsibilities

• Serve as the clinical lead on cross-functional development program teams to develop and execute overall clinical development strategy
• Lead the development of clinical trial design, study protocols, investigator brochures, and clinical study reports
• Partner with Clinical Operations to execute trials, including recruitment, enrollment, and data management
• Collaborate with Biostatistics, Regulatory Affairs, and Medical Affairs to ensure high-quality program execution
• Support medical monitors in evaluating safety data and contributing to risk assessment and mitigation plans
• Lead preparation for and serve as medical representative for Data Monitoring Committees (DMCs) and Safety Review Committees (SRC)
• Contribute to regulatory submissions (IND/CTAs) and participate in health authority agency interactions (FDA/EMA)
• Provide clinical insights to support business development and due diligence activities

Requirements

• MD, PhD, or PharmD in a relevant life sciences discipline
• Minimum 8–12+ years of experience in clinical research and drug development within biotech/pharma
• Demonstrated experience leading clinical programs and interacting with regulatory authorities
• Proven track record of successful IND/CTA submissions
• Strong understanding of clinical trial design, endpoint development, and statistical analyses
• Experience across multiple phases of drug development

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.