Senior Clinical Operations Leader — Trials & Strategy

PTC Therapeutics, Inc; New Jersey; Hybrid; USD 170,000 - 214,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to lead the end-to-end life cycle of clinical trials across therapeutic areas.

You will manage study design, timelines, site management, data review, and reporting, working with internal and external partners to meet regulatory requirements. The role requires strong leadership, strategic thinking, and hands-on experience with GMP/GCP/ICH guidelines.

Qualifications

• Bachelor's degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research.
• Strong knowledge of the drug development process and regulatory guidelines (GCP/ICH).
• Experience writing and editing clinical documents and managing trial protocols.

Responsibilities

• Lead, direct and contribute to planning, execution, and reporting of clinical trials across indications.
• Manage timelines, budgeting, site selection, CRO management, data review and study reporting.
• Coordinate regulatory submissions and communications with health authorities and investigators.
• Mentor and coach direct reports and cross-functional team members.
• Interface with investigators and internal teams to align clinical strategy and study plans.

Skills

Communication skills

Analytical thinking

Time management

Collaboration

Education

Bachelor's degree in scientific discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Project

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to lead the end-to-end life cycle of clinical trials across therapeutic areas.

You will manage study design, timelines, site management, data review, and reporting, working with internal and external partners to meet regulatory requirements. The role requires strong leadership, strategic thinking, and hands-on experience with GMP/GCP/ICH guidelines.