Senior Clinical Operations Lead — Global Trials

PTC Therapeutics, Inc; Maryland; Hybrid; USD 137,000 - 172,000; Full time

Benefits offered by this job

Incentives

Medical benefits

Retirement plan

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to oversee the planning, execution, and oversight of clinical trials across our development programs. This role may serve as Lead Clinical Trial Manager or key operational contributor within a program team.

The incumbent ensures trials are conducted in compliance with ICH-GCP, global regulations, SOPs, and study protocols, while managing timelines, budgets, and mentor junior staff. Travel ~20% is expected.

Qualifications

• Bachelor's degree in a scientific discipline and 7+ years in clinical research.
• Strong knowledge of ICH-GCP guidelines and global trial regulations.
• Ability to lead clinical trial operations and cross-functional teams.
• Experience with risk-based quality management and vendor oversight.

Responsibilities

• Lead or support the operational execution of Phase I-IV clinical trials, depending on study complexity and program needs.
• Serve as Lead Clinical Trial Manager for assigned studies, with responsibility for study timelines, operational strategy, and study deliverables.
• Contribute to development planning and operational feasibility assessments.
• Develop and manage key study documents including: Clinical Trial Management Plans, Study timelines and milestone tracking, Vendor scopes of work and operational budgets.
• Oversee study start-up, conduct, and close-out activities.
• Provide operational oversight of Clinical CROs and other service providers to ensure delivery of services.
• Monitor service provider performance, study metrics, and KPIs to ensure study quality and timelines.
• Partner with internal functions to align operational study plans with program timelines.

Skills

Project management

Cross-functional leadership

Regulatory knowledge

Risk management

Vendor oversight

Mentoring

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 oversee the planning, execution, and oversight of clinical trials across our development programs. This role may serve as Lead Clinical Trial Manager or key operational contributor within a program team.

The incumbent ensures trials are conducted in compliance with ICH-GCP, global regulations, SOPs, and study protocols, while managing timelines, budgets, and mentor junior staff. Travel ~20% is expected.