Director, Clinical Systems and Integration

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:

Job Description:

The Director, Clinical Systems and Integration drives the strategic development, implementation, and optimization of clinical systems to support the organization’s research and development objectives.

This position ensures that clinical systems are robust, scalable, and fully aligned with business needs, regulatory requirements and industry best practices. The role demands a combination of technical and industry expertise, strong leadership, and creative problem-solving to identify and implement improvements to the PTC clinical systems and supporting integrations.

Collaborating with cross-functional teams, the Director for Clinical Systems and Integration ensures operational efficiency, data integrity, and adherence to regulatory regulations. In addition, this position is responsible for:

• Providing subject matter expertise to clinical study teams during all phases of the project life cycle, including electronic data capture, system integration, reporting and external data standardization.

• Serving as a liaison between business functions, functional areas, and technology for data-related clinical requirements.

• Being an SME on applications, products, and tools used in clinical system landscape, currently and forward-looking.

He/She manages direct reports.

The Director, Clinical Systems and Integration leads the development, implementation, and optimization of clinical systems and integrations to support on-going and future clinical trials and research initiatives. By integrating technology, the Director ensures that data systems are robust, compliant, and aligned with overall organizational goals.

The Director, Clinical Systems and Integration ensures adherence to regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS

• Serves as a liaison between business and relevant functional areas for system and integration requirements.

• Identifies and implements opportunities for streamlining processes.

• Creates and maintains data processes and standards, ensuring seamless integration between clinical systems to ensure high quality data from all types of data sources and systems.

• Manages, coaches and develops direct reports to participate effectively in the identification, implementation and on-going maintenance of clinical systems in PTC.

• Manage small and large project teams comprising of members from cross-functional groups and external vendors to perform, for instance, assessments, configurations, implementations of clinical systems or enhancements. This may include requirements gathering and business process definition to successfully lead the team to meet their objectives.

• Develops SOPs and training guidelines related to clinical systems and their intended use for department and cross-functional usage.

• Designs, configures, develops and maintains PTC’s Case Report Form (CRF) Standard Library.

• Gathers requirements related to existing clinical systems to identify opportunities to enhance, improve and streamline processes and systems use.

• Leads the assessment and selection of vendors and systems.

• Identifies and assesses trends in business and technology to inform PTC management on an on-going basis.

• Supports and contributes to regulatory submissions and audit/inspection activities.

• Builds relationships with vendors, providing outsourcing solutions, creating requests for proposals (RFPs), reviewing and commenting on vendor proposals, and representing the team at cross-functional meetings.

• 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.

• Master’s degree in quantitative sciences discipline (e.g., Engineering, Mathematics, or Computer Science) and a minimum of 8 years of progressively