Senior Clinical Operations Lead — Trials & Strategy

PTC Therapeutics, Inc; Massachusetts; Vor Ort; USD 170.000 - 214.000; Vollzeit

Zusammenfassung

PTC Therapeutics, Inc. in Massachusetts is seeking an Associate Director, Clinical Operations to lead execution of clinical trials across indications.

You will manage study design, timelines, budgets, site management, regulatory submissions, and cross-functional collaboration with internal teams and external CROs. The role requires strong leadership, expert knowledge of GxP, ICH guidelines, and hands-on experience in trial oversight, data review, and mentoring direct reports.

Qualifikationen

• Bachelor's degree in a scientific discipline and 7+ years of clinical research experience.
• Strong knowledge of GMP, GCP, and ICH guidelines.
• Ability to lead trials, plan timelines, manage budgets and mentor staff.

Aufgaben

• Lead planning, execution, and reporting of clinical trials with timelines and CRO management.
• Develop strategies with investigators; prepare study protocols and regulatory documents.
• Manage budgets, timelines, vendor contracts, and cross-functional communication.

Kenntnisse

Clinical trial design

Project management

Regulatory submissions

Budget management

Vendor management

Data review

Team leadership

Cross-functional collaboration

GxP guidelines knowledge

Ausbildung

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

PowerPoint

Jobbeschreibung

PTC Therapeutics, Inc. in Massachusetts is seeking an Associate Director, Clinical Operations to lead execution of clinical trials across indications.

You will manage study design, timelines, budgets, site management, regulatory submissions, and cross-functional collaboration with internal teams and external CROs. The role requires strong leadership, expert knowledge of GxP, ICH guidelines, and hands-on experience in trial oversight, data review, and mentoring direct reports.