Senior Clinical Operations Leader

PTC Therapeutics, Inc.

Delaware

On-site

USD 170,000 - 214,000

Full time

40 hours ago
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Benefits offered by this job

Short- and long-term incentives
Medical, dental, vision, and 401(k)

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to lead the full life‑cycle execution of clinical trials across indications within therapeutic areas.

You will work with the clinical team to design, conduct, and close out studies, while managing timelines, budgets, and CRO relationships. The role requires directing study design, protocol development, site management, and regulatory submissions, with responsibility to mentor direct reports and maintain compliance with

Qualifications

  • Bachelor’s degree in a scientific discipline and 7+ years of global clinical research experience.
  • Knowledge of GMP, GCP, and ICH guidelines.
  • Ability to manage timelines, budgets, and vendor relationships.
  • Experience coordinating cross‑functional teams in a fast-paced environment.

Responsibilities

  • Lead and contribute to planning, execution, and reporting of clinical trials.
  • Interact with internal and external teams to develop strategies and plans.
  • Prepare study protocols and related regulatory documents.
  • Manage investigational sites, budgets, and vendor contracts; coordinate investigator meetings.
  • Monitor timelines and prepare progress reports for internal and external review.
  • Support regulatory submissions and communications with authorities.
  • Mentor and develop direct reports.

Skills

GMP/GCP/ICH
Clinical trial design
Regulatory submissions
Team leadership
Data interpretation
MS Word & Excel
Project management

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word
Excel
Microsoft Project
PowerPoint

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to lead the full life‑cycle execution of clinical trials across indications within therapeutic areas.

You will work with the clinical team to design, conduct, and close out studies, while managing timelines, budgets, and CRO relationships. The role requires directing study design, protocol development, site management, and regulatory submissions, with responsibility to mentor direct reports and maintain compliance with

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