Senior Director, Analytical Development

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Analytical Development based in the United States. This executive-level role offers the opportunity to lead analytical development and quality control strategy across a growing pharmaceutical pipeline, from early development through commercial launch and post-approval lifecycle management. You’ll combine deep scientific expertise with hands-on leadership, shaping analytical methods, control strategies, and GMP operations for small-molecule oral solid dosage products and future modalities. Working across internal teams and external laboratories, you’ll ensure analytical readiness, data integrity, and regulatory compliance while supporting critical development milestones. You’ll also play a central role in preparing and authoring CMC submission content, engaging with FDA regulators, and guiding responses to technical questions and inspections. In a lean, virtual, growth-stage environment, you’ll build and develop a high-performing analytical organization while balancing strategic decisions with direct technical contribution. This is a remote position within the United States.