Clinical Operations Lead - Trials & Programs

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

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision insurance

Retirement savings plan

Job summary

PTC Therapeutics, Inc. seeks a Senior Manager, Clinical Operations to lead and oversee the execution of Phase I-IV trials, ensuring compliance with ICH-GCP and company SOPs across global sites.

You will mentor junior staff, manage timelines and budgets, collaborate with cross-functional teams, and oversee CROs and service providers to deliver high-quality data.

This role requires strong leadership, risk management, and communication skills, with travel up to ~20%.

Qualifications

• Bachelor's degree in a scientific discipline and a minimum of 7 years of progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO or related environment OR equivalent education and/or experience.
• 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.
• Contribute to the 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.

Skills

ICH-GCP knowledge

Clinical trial operations

Cross-functional leadership

Vendor oversight

Project management

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

PTC Therapeutics, Inc. seeks a Senior Manager, Clinical Operations to lead and oversee the execution of Phase I-IV trials, ensuring compliance with ICH-GCP and company SOPs across global sites.

You will mentor junior staff, manage timelines and budgets, collaborate with cross-functional teams, and oversee CROs and service providers to deliver high-quality data.

This role requires strong leadership, risk management, and communication skills, with travel up to ~20%.