Associate Director, Clinical Systems and Integration Specialist

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

The Associate 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 Associate Director. 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.

The Associate 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 Associate Director ensures that data systems are robust, compliant, and aligned with overall organizational goals.

The Associate Director, Clinical Systems and Integration supports 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.

• 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.

• 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 responsible experience supporting the configuration and implementation of clinical systems within the pharmaceutical, biotechnology, and/or healthcare industries.

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

• A proven track record of successful leadership of cross-functional teams to implement clinical systems and integrations to enhance operational efficiency and compliance.

• Previous IT support experience (for example, a Systems Administration function), including maintenance and ongoing management of computerized systems.

• Knowledge of data analysis and reporting processes related to clinical development.

• Ability to influence without direct authority.

• Proficiency with Microsoft Office applications.

• Excellent verbal and written communications skills.

• Detailed oriented and service minded.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• An 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.

• Systems Implementation experience in a regulated Industry.

• Ability to quickly understand and triage support questions and ensure that corrective actions are taken and confirm that the issues are resolved on a timely basis.

• Knowledge of different regulatory standards and requirements, including but not limited to FDA, EMEA, and PMDA.

• Working knowledge of EDC systems such as Medidata and its product suite (e.g. RAVE EDC, CODER, Imaging, Payments, CTMS) or equivalent.

*Special knowledge or skills and/or licenses or certificates preferred.

• Understanding and knowledge of Computer Systems Validation.

• Understanding of Compliance and Regulations, such as ICH, GxP, Annex 11, GDPR and GAMP.

• Understanding of the use of risk-based approach for process efficiency and compliance.

• Understanding of programming languages, for instance in SAS, Phyton and/or R.

• Understanding of access and security controls for computerized applications, networking and file systems.

• IT skills include understanding of Operating System, Active Directory, application, database structures, data storage, communication protocols and networking.

• Experience with practical utilization of Artificial Intelligence (AI) tools, such as ChatGPT, Meta, Gemini etc., preferably in the pharmaceutical industry.

• Understanding of SDLC & IT Tools - e.g. JIRA, Confluence, eTMF, ServiceNow, Smartsheet, and Teams/SharePoint.

• Clinical Data Interchange Standards Consortium (CDISC) experience.

* Travel requirements

• 0 - 10%

Expected Base Salary Range

$149,100 - $187,700. 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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