Clinical Operations Lead - Trials Delivery

Regulatory Jobs; New Jersey; Hybrid; USD 137,000 - 172,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision coverage

Retirement savings plans

Hybrid work

Job summary

PTC Therapeutics, a global biopharmaceutical company, is seeking a Senior Manager, Clinical Operations in New Jersey. You will oversee operational planning, execution, and oversight of Phase I–IV trials, ensuring compliance with ICH-GCP, SOPs, and study protocols.

The role leads cross-functional teams, manages study budgets and timelines, mentors staff, and drives vendor oversight. Travel about 20% is expected; base salary ranges from $136,600 to $171,900, with incentives.

Qualifications

• Bachelor’s degree in a scientific discipline; minimum 7 years of US/global clinical research experience or equivalent.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Experience leading clinical trial operations and cross-functional teams.
• Leadership experience and ability to mentor junior staff.

Responsibilities

• Lead or support operational execution of Phase I–IV trials; manage timelines and strategy.
• Serve as Lead Clinical Trial Manager for assigned studies; oversee study start-up, conduct, and close-out.
• Oversee CROs and service providers; participate in vendor selection and contracts.
• Monitor study metrics, budgets, and timelines; implement risk mitigation.
• Partner with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, and Quality Assurance.
• Provide mentorship and performance management for team members.
• Ensure study documentation is inspection-ready and compliant with SOPs.

Skills

Leadership

Project management

Communication

Analytical thinking

Risk management

Cross-functional collaboration

Microsoft Office

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

PTC Therapeutics, a global biopharmaceutical company, is seeking a Senior Manager, Clinical Operations in New Jersey. You will oversee operational planning, execution, and oversight of Phase I–IV trials, ensuring compliance with ICH-GCP, SOPs, and study protocols.

The role leads cross-functional teams, manages study budgets and timelines, mentors staff, and drives vendor oversight. Travel about 20% is expected; base salary ranges from $136,600 to $171,900, with incentives.