Clinical Operations Lead: Trials Strategy & Delivery

PTC Therapeutics, Inc; Maryland; On-site; USD 170,000 - 214,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision coverage

Retirement savings plans

Job summary

PTC Therapeutics, Inc. in the United States seeks an Associate Director, Clinical Operations to lead end-to-end clinical trial execution across indications. You will manage study design through closeout, supervise staff, and collaborate cross-functionally with internal and external teams.

The role emphasizes regulatory compliance, SOP adherence, and data integrity. Responsibilities include timelines, budgets, site management, CRO oversight, and preparation of submissions while mentoring team

Qualifications

• Bachelor's degree in a scientific discipline and 7+ years in clinical research.
• Experience in clinical trial design, conduct, data acquisition and reporting.
• Familiarity with GMP, GCP and ICH guidelines; strong regulatory exposure.
• Ability to lead, influence and mentor in a cross-functional team.

Responsibilities

• Lead planning, execution and reporting of clinical trials across indications.
• Manage timelines, budgets, site selection, CROs and data review.
• Develop strategies for safety, eligibility, enrollment and data integrity.
• Prepare regulatory documents and support submissions; mentor staff.

Skills

Clinical trial leadership

Project management

Regulatory submissions

Vendor management

Cross-functional collaboration

GMP/GCP/ICH knowledge

Communication skills

Mentoring

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Excel

PowerPoint

Microsoft Project

Job description

PTC Therapeutics, Inc. in the United States seeks an Associate Director, Clinical Operations to lead end-to-end clinical trial execution across indications. You will manage study design through closeout, supervise staff, and collaborate cross-functionally with internal and external teams.

The role emphasizes regulatory compliance, SOP adherence, and data integrity. Responsibilities include timelines, budgets, site management, CRO oversight, and preparation of submissions while mentoring team