Senior Clinical Operations Leader (Phase I–IV)

PTC Therapeutics, Inc.; Maryland; On-site; USD 137,000 - 172,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision coverage

Retirement savings plans

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to plan, execute, and oversee Phase I–IV trials. You will lead study timelines, budgets, and operational strategy while mentoring junior staff. Strong ICH-GCP knowledge and cross-functional collaboration are essential for success.

The role requires navigating global regulatory requirements, managing vendor relationships, and ensuring inspection readiness with a focus on quality and timelines. Travel is approximately 20%.

Qualifications

• Bachelor’s degree in a scientific discipline with at least 7 years of global clinical research experience.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Ability to lead clinical trial operations and cross-functional teams.
• Experience with risk-based quality management and vendor oversight.
• Excellent communication, collaboration, and problem-solving abilities.
• Willingness to travel up to 20%.

Responsibilities

• Lead or support the execution of Phase I-IV clinical trials across programs.
• Serve as Lead Clinical Trial Manager for assigned studies.
• Develop study documents and budgets; monitor timelines and milestones.
• Oversee CROs and service providers and ensure contract compliance.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, and QA.
• Support inspection readiness and audit follow-up.
• Identify operational risks and implement mitigations.

Skills

Clinical operations leadership

Project management

Cross-functional collaboration

Communication skills

Analytical thinking

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 plan, execute, and oversee Phase I–IV trials. You will lead study timelines, budgets, and operational strategy while mentoring junior staff. Strong ICH-GCP knowledge and cross-functional collaboration are essential for success.

The role requires navigating global regulatory requirements, managing vendor relationships, and ensuring inspection readiness with a focus on quality and timelines. Travel is approximately 20%.