Associate Director, Clinical Operations - Lead Trials

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

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision

Retirement savings plan

Job summary

PTC Therapeutics, Inc. seeks an Associate Director, Clinical Operations to lead the end‑to‑end life cycle of clinical trials across indications. You will manage study design, timelines, site selection, budgeting and data review as part of a cross‑functional team.

In this role, you will collaborate with investigators and internal stakeholders, drive regulatory submissions, and oversee mentor-mentee relationships. A strong GMP/GCP/ICH background and excellent communication are essential.

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research.
• Experience with protocol development, CRF design, site selection and budgeting.
• Familiarity with GMP, GCP and ICH guidelines; ability to interpret clinical data.

Responsibilities

• Lead, direct and contribute to planning, execution, and reporting of clinical trials, including timelines, protocol writing, site management, drug forecasting, and data review.
• Interact with internal and external team members to develop clinical strategies and study plans.
• Prepare and edit study protocols, amendments, manuals, informed consent forms, and associated documents.
• Manage investigation sites, budgets, contracts, and investigator meetings; respond to site questions.
• Manage study timelines and budgets; present progress at team and investigator meetings.
• Support regulatory submissions and communications; contribute to reports for agencies and journals.
• Mentor and guide direct reports; travel up to 20% as needed.

Skills

Clinical operations

Project management

Regulatory understanding

Data review and reporting

Communication skills

GMP/GCP/ICH knowledge

Mentoring

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

PowerPoint

Job description

PTC Therapeutics, Inc. seeks an Associate Director, Clinical Operations to lead the end‑to‑end life cycle of clinical trials across indications. You will manage study design, timelines, site selection, budgeting and data review as part of a cross‑functional team.

In this role, you will collaborate with investigators and internal stakeholders, drive regulatory submissions, and oversee mentor-mentee relationships. A strong GMP/GCP/ICH background and excellent communication are essential.