Global Clinical Operations Lead

PTC Therapeutics, Inc.; New York (NY); Vor Ort; USD 170.000 - 214.000; Vollzeit

Zusammenfassung

PTC Therapeutics, Inc. is seeking an Associate Director of Clinical Operations to lead the end-to-end lifecycle of clinical trials across multiple indications, ensuring regulatory compliance and cross-functional collaboration.

The role involves protocol development, site management, budgeting, timelines, and data review, with potential for manager responsibilities and cross-team coordination in a dynamic, global environment.

Qualifikationen

• Bachelor’s degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO, university medical center or related environment.
• Hands-on experience supporting regulatory submissions and communicating with regulatory agencies.

Aufgaben

• Leads the planning, execution, and reporting of clinical trials across indications, including timelines, site management, and data review.
• Prepares and edits study protocols, consent forms, and related documentation.
• Manages budgets, timelines, and CRO relationships; conducts investigator meetings and presents progress.
• Coaches and mentors direct reports and works cross-functionally with teams.

Kenntnisse

Clinical research experience

Project management

Regulatory submissions

GMP/GCP/ICH knowledge

Data review & reporting

Team leadership

Microsoft Word/Excel

Microsoft Project

PowerPoint

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

PowerPoint

Jobbeschreibung

PTC Therapeutics, Inc. is seeking an Associate Director of Clinical Operations to lead the end-to-end lifecycle of clinical trials across multiple indications, ensuring regulatory compliance and cross-functional collaboration.

The role involves protocol development, site management, budgeting, timelines, and data review, with potential for manager responsibilities and cross-team coordination in a dynamic, global environment.