Associate Director, Clinical Operations Excellence – Standards Lead

PTC Therapeutics, Inc.

Associate Director leading Clinical Operations Excellence – Standards within PTC Therapeutics. Responsible for executing vision and strategy for high-quality standards in clinical operations.

Posted 6/25/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $170,200 - $214,200 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Collaborates with department leadership to create, establish, improve, and maintain operational processes
Leads and contributes to the development of departmental SOPs, guidance documents, and policies
Oversees the framework of processes within Clinical Operations to ensure continuity and transparency
Develops and assesses training for SOPs, working practices, and forms
Serves as primary contact for standards-related requests
Participates in reviews and working groups
Authors, updates, and manages Clinical Operations SOPs and templates
Ensures document version control, archival, and periodic review processes are followed
Partners with Clinical Operation leaders and study teams
Develops and executes rollout plans for new and revised standards
Monitors adoption and effectiveness of standards
Gathers user feedback and analyzes issues/trends

Requirements

What you’ll need

Bachelor’s degree in a relevant discipline
Minimum of 8 years of clinical operations and/or clinical trial operations experience
Demonstrated experience authoring and implementing SOPs, templates, work instructions, or other controlled documents in a regulated environment
Strong understanding of GCP/ICH principles and clinical trial lifecycle activities
Proficiency with Microsoft Office
Excellent verbal and written communication skills
Ability to work independently and collaboratively
Analytical thinker with excellent problem-solving skills
Excellent planning, organization and time management skills
Travel requirements 20-30%

Benefits

Comp & perks

Short- and long-term incentives
Medical, dental, and vision plans
Retirement savings plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SOP authoringdocument version controltraining developmentclinical trial operationsGCP principlesICH principlesanalytical skillsproblem-solving skillsplanning skillstime management

Soft Skills

collaborationcommunicationindependenceteamworkorganizational skillsleadershipfeedback gatheringtrend analysisadaptabilitytransparency

Certifications

Bachelor’s degree