Join the Sentynl team

Director, Clinical Operations

The Director of Clinical Operations will provide strategic and operational leadership in the planning, execution, and oversight of clinical study programs across the full development lifecycle (Phase 2/3 through Phase 4). This role is accountable for the successful delivery of studies within the Clinical Development Plan whether conducted in-house or outsourced to third-party vendors. Working cross-functionally with internal stakeholders and external partners, the Director, Clinical Operations will manage timelines, budgets, and resources while ensuring regulatory compliance and operational excellence.

Associate Director, Regulatory Affairs

The Associate Director of Regulatory Affairs is responsible for managing day-to-day Global Regulatory Affairs activities related to Sentynl’s development and commercial pharmaceutical programs. The Associate Director, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for U.S. and global programs and will work closely with the VP of Regulatory Affairs and Quality to prepare regulatory submissions (authoring, reviewing, timeline planning, etc.), to support regulatory objectives. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, contract manufacturing organizations, electronic publishing vendors, and other service providers as required. The candidate must have a strong knowledge of cGMP regulations/systems, FDA EMA, and other applicable global territory regulations, and have the ability to make independent decisions based on regulations and requirements. This individual must demonstrate excellent leadership, communication, critical thinking, and organizational skills.