Senior Clinical Operations Lead - Trials & Strategy

PTC Therapeutics, Inc; Washington (District of Columbia); On-site; USD 137,000 - 172,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead and oversee global clinical trials across phases I–IV, ensuring quality, timelines, and budget alignment.

You will partner with cross‑functional teams and external CROs to drive study execution, document development, and risk management, while mentoring junior staff and supporting inspection readiness. Travel about 20% is expected.

Qualifications

• Bachelor's degree in a scientific discipline and a minimum of 7 years of progressively responsible U.S. and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO or related environment.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Demonstrated ability to lead clinical trial operations and cross‑functional teams.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports (if managing people).
• Strong project management and organizational skills.

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.
• Develop and manage key study documents including: CTMPs, study timelines, 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 key performance indicators to ensure study quality and timelines.
• Contribute to study budget development and ongoing financial oversight.
• May manage and develop direct reports; provide mentorship and training to team members.
• Ensure study documentation is maintained and inspection ready.

Skills

Clinical trial management

Cross‑functional leadership

Vendor oversight

Project management

ICH-GCP knowledge

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead and oversee global clinical trials across phases I–IV, ensuring quality, timelines, and budget alignment.

You will partner with cross‑functional teams and external CROs to drive study execution, document development, and risk management, while mentoring junior staff and supporting inspection readiness. Travel about 20% is expected.