Director, Drug Product Development (Clinical-Stage)

Clinical Dynamix, Inc.; Jersey City (NJ); Vor Ort; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

Clinical Dynamix, Inc. is seeking an experienced Director of Drug Product Development to lead formulation, manufacturing, and lifecycle activities across the clinical-stage portfolio.

This role partners with CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure robust, scalable drug products aligned with program timelines. The candidate will drive development strategies, oversee CDMOs/CMOs, and contribute to regulatory submissions while mentoring teams in a fast-paced,

Qualifikationen

• Ph.D. in Pharmaceutical Sciences or related field with 12+ years in drug product development.
• Hands-on leadership of drug product development and CMC activities for small molecule programs.
• Experience with CDMOs/CMOs and external partners; strong regulatory liaison.
• Proven track record advancing programs through development milestones and regulatory submissions.

Aufgaben

• Lead drug product development strategy across the clinical-stage portfolio.
• Oversee formulation design, process development, manufacturability, and lifecycle planning.
• Manage external manufacturers to ensure timely execution and quality.
• Contribute to CMC regulatory strategy and submissions as needed.
• Collaborate across Regulatory, Quality, Analytical Development, and Clinical Operations to align plans.

Kenntnisse

Drug product development

CMC

Regulatory submissions

Cross-functional leadership

Project management

External manufacturing

IND-enabling

Communication

Leadership

Ausbildung

PhD in Pharmaceutical Sciences

MS in a related field

Jobbeschreibung

Clinical Dynamix, Inc. is seeking an experienced Director of Drug Product Development to lead formulation, manufacturing, and lifecycle activities across the clinical-stage portfolio.

This role partners with CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure robust, scalable drug products aligned with program timelines. The candidate will drive development strategies, oversee CDMOs/CMOs, and contribute to regulatory submissions while mentoring teams in a fast-paced,