Associate Director, Clinical Operations Excellence - Standards Lead

PTC Therapeutics, Inc.•Remote(US-California), CA

1d•$170,200 - $214,200•Onsite

About The Position

The Associate Director, Clinical Operations Excellence – Standards Lead is responsible for executing the vision and strategy set by the Director, Clinical Operations Excellence – Standards to drive consistent, high-quality ways of working across the Clinical Operations organization. This role serves as the primary point of contact for internal stakeholders on Clinical Operations standards and is accountable for ensuring standards are implemented effectively through stakeholder engagement, training/communication support, and ongoing monitoring of adoption. The Associate Director, Clinical Operations Excellence – Standards Lead will partner closely with Clinical Trial Management, Quality Assurance, and Quality Operations to develop, maintain, and deploy Clinical Operations SOPs, templates, tools, and work instructions. She/He manages direct report(s). The Associate Director, Clinical Operations Excellence - Standards Lead supports adherence to relevant regulatory requirements, and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Bachelor’s degree in a relevant discipline and a minimum of 8 years of clinical operations and/or clinical trial operations experience, including exposure to SOPs/quality documents and process improvement within the biotechnology or pharmaceutical industry.
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.
Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Responsibilities

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 in support of study management in adherence to good clinical practices (GCPs).
Develops, assesses, and/or provides training for SOPs, working practices, and forms, as needed, to ensure compliance.
Serves as primary contact for standards-related requests and provides necessary support to project team members on GCP issues that arise.
Participates in reviews and working groups as needed to ensure standards are aligned, practical, and consistently applied.
Authors, updates, and manages Clinical Operations SOPs, templates, and work instructions, ensuring clarity, usability, and compliance with applicable regulations and internal quality requirements.
Leads cross-functional authoring and review cycles, coordinating input from Clinical Operations, Quality, and other impacted departments (e.g. Clinical Development, Regulatory, Data Management, Clinical Supplies, Pharmacovigilance) as applicable.
Ensures document version control, archival, and periodic review processes are followed.
Partners with Clinical Operation leaders and study teams to embed standards into day-to-day execution, including study start-up and trial delivery practices.
Develops and executes rollout plans for new and revised standards (communication, training, and stakeholder alignment).
Monitors adoption and effectiveness of standards; identify gaps and drive corrective actions (e.g., refresher training, template improvements).
Gathers user feedback and analyze issues/trends to continuously improve standards, templates, and guidance.
Supports inspections/audits by providing documentation and evidence of standards governance and implementation, as needed.
Benchmarks industry practices and incorporate learnings to strengthen Clinical Operations ways of working.
Supports alignment and consistency of standards across outsourced activities and vendor-managed processes where applicable.
Manages, coaches and mentors direct reports.
Performs other tasks and assignments as needed and specified by management.