Global Clinical Operations Lead

PTC Therapeutics Inc.; Pennsylvania; On-site; USD 170,000 - 214,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision, and 401(k)

Job summary

PTC Therapeutics is seeking an Associate Director of Clinical Operations to oversee the full lifecycle of multiple clinical trials across therapeutic areas. The role requires leading the clinical team, coordinating with external vendors, and ensuring regulatory compliance and SOP adherence.

You will manage timelines, budgets, and data review while mentoring direct reports and liaising with investigators and internal scientists to ensure robust trial execution and reporting.

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research in pharma, biotech, CRO, university medical centers, or related environments.
• Working knowledge of the drug development process, clinical trial design, conduct, data acquisition and reporting.
• Experience with GMP, GCP, and ICH guidelines; ability to influence without direct authority.

Responsibilities

• Lead planning, execution, and reporting of clinical trials; estimate timelines and design CRFs, site selection, drug forecasting, and CRO management.
• Collaborate with internal/external teams to develop clinical strategies, trial designs, and project deliverables.
• Prepare and edit study protocols, amendments, manuals, consent forms, and regulatory submissions.
• Develop investigator site lists, manage budgets, and coordinate investigator meetings.

Skills

Clinical research

GCP/ICH/GMP

Project management

Regulatory submissions

Team leadership

Budgeting

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Excel

Microsoft Project

PowerPoint

Job description

PTC Therapeutics is seeking an Associate Director of Clinical Operations to oversee the full lifecycle of multiple clinical trials across therapeutic areas. The role requires leading the clinical team, coordinating with external vendors, and ensuring regulatory compliance and SOP adherence.

You will manage timelines, budgets, and data review while mentoring direct reports and liaising with investigators and internal scientists to ensure robust trial execution and reporting.