Director, Pharmaceutical Development

Role: Senior leader responsible for small molecule drug product development, focusing on oral and topical formulations from early to late-stage clinical phases and commercial launch. Key responsibilities include leading QbD-based formulation and process development, applying expertise in solubility enhancement technologies (e.g., amorphous dispersions, lipid systems, nano-formulations), overseeing scale-up and technology transfer, managing late-stage regulatory activities, and directing external CDMO partnerships. The role requires ensuring process robustness, regulatory compliance (IND/NDA submissions), and cross-functional collaboration across R&D, manufacturing, and regulatory teams. Qualifications: Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related field; 12+ years in pharmaceutical development, with significant expertise in small molecule oral/topical formulations, late-stage development, and regulatory submission experience. Preferred skills include hands-on knowledge of QbD methodologies, experience managing CDMOs, and leadership in a fast-paced environment. High-value specifics: focus on chemically synthesized small molecules, late-stage clinical development, GMP compliance, and cross-functional stakeholder engagement. Work setup: primarily on-site in Brisbane, CA; approximately 25% travel, including domestic and international site visits.