Senior Clinical Operations Lead, Global Trials

PTC Therapeutics; New Jersey; On-site; USD 170,000 - 214,000; Full time

Job summary

PTC Therapeutics is seeking an Associate Director, Clinical Operations to drive the end-to-end life cycle of clinical trials, overseeing study design through close-out and ensuring alignment with regulatory requirements.

You will collaborate with internal departments and external resources, guide timelines and budgets, and oversee data and reporting to support trial success. Travel up to 20% may be required.

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research.
• Special knowledge of the drug development process and understanding of GMP, GCP, ICH guidelines.
• Ability to lead and collaborate in a fast-paced, matrixed environment.

Responsibilities

• Lead, direct and contribute to planning, execution and reporting of clinical trials, including timelines, protocol design, CRF design, site management and data review.
• Interacts with internal and external teams to develop clinical strategies, trial designs and deliverables.
• Prepare documents for regulatory submissions and maintain quality of trial data.

Skills

Verbal communication

Written communication

Leadership

Project management

GMP/GCP/ICH knowledge

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Excel

Microsoft Project

PowerPoint

Job description

PTC Therapeutics is seeking an Associate Director, Clinical Operations to drive the end-to-end life cycle of clinical trials, overseeing study design through close-out and ensuring alignment with regulatory requirements.

You will collaborate with internal departments and external resources, guide timelines and budgets, and oversee data and reporting to support trial success. Travel up to 20% may be required.