Clinical Operations Lead — Trials Strategy & Execution

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

Benefits offered by this job

Incentives program

Medical/Dental/Vision benefits

Retirement plans

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director of Clinical Operations to lead end-to-end clinical trial execution across indications. You will work with a cross-functional clinical team to design studies, oversee timelines, and ensure data integrity while aligning with regulatory requirements.

The role involves managing trial budgets, coordinating investigator meetings, and mentoring junior staff in a fast-paced, matrixed environment. Competitive compensation and incentives are offered.

Qualifications

• Bachelor's degree in a scientific discipline and 7+ years of clinical research experience.
• Experience in US/global trials within pharma, biotech, CRO, or academic settings.
• Knowledge of GMP, GCP and ICH guidelines; strong regulatory understanding.

Responsibilities

• Lead planning, execution, and reporting of trials; manage timelines, CRF design, site selection, and budgeting.
• Collaborate with internal/external teams; obtain direction from investigators and clinical staff.
• Develop study protocols, amendments, manuals, and informed consent documents.
• Mentor and coach direct reports; manage project teams and vendor relationships.
• Support regulatory submissions and communications with agencies.

Skills

Clinical Operations

Project Management

GCP/GMP/ICH

Regulatory Knowledge

Leadership

Communication

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Excel

Microsoft Project

PowerPoint

Job description

PTC Therapeutics, Inc. is seeking an Associate Director of Clinical Operations to lead end-to-end clinical trial execution across indications. You will work with a cross-functional clinical team to design studies, oversee timelines, and ensure data integrity while aligning with regulatory requirements.

The role involves managing trial budgets, coordinating investigator meetings, and mentoring junior staff in a fast-paced, matrixed environment. Competitive compensation and incentives are offered.