Associate Director, Clinical Operations Excellence - Standards Lead

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

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.
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Job Description:

ESSENTIAL FUNCTIONS

Primary duties/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. Additionally, 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.  

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• 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.

* Special knowledge or skills needed and/or licenses or certificates required.

• 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. 

* Travel requirements

• 20-30%

Expected Base Salary Range: $170,200 - $214,200. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

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EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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