Senior Clinical Operations Lead – Global Trials

PTC Therapeutics, Inc; Lynnfield (MA); On-site; USD 137,000 - 172,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead planning, execution, and oversight of Phase I–IV trials across development programs.

You may serve as Lead Clinical Trial Manager or contribute as a key operational leader within a program team. You will ensure trials comply with ICH-GCP, regulations, SOPs, and study protocols, collaborating with internal teams and external CROs to deliver quality, on-time results within budget.

Qualifications

• Bachelor's degree in a scientific discipline and 7+ years of clinical research experience in pharma, biotech, or CRO.
• Strong knowledge of ICH-GCP guidelines and global regulatory requirements.
• Experience leading clinical trial operations and coaching junior staff.

Responsibilities

• Lead or support Phase I–IV trials, with timelines, strategy, and deliverables responsibility.
• Oversee CROs and vendors to ensure quality, budget, and schedules.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, and QA.
• Support inspection readiness and develop risk mitigation plans.

Skills

Clinical operations leadership

Project management

Regulatory knowledge

Vendor oversight

Cross-functional collaboration

Communication skills

Problem-solving

Leadership coaching

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead planning, execution, and oversight of Phase I–IV trials across development programs.

You may serve as Lead Clinical Trial Manager or contribute as a key operational leader within a program team. You will ensure trials comply with ICH-GCP, regulations, SOPs, and study protocols, collaborating with internal teams and external CROs to deliver quality, on-time results within budget.