Associate Director, Enterprise Applications

Summary

Join Tarsus Pharmaceuticals as an Associate Director, Enterprise Applications – R&D Systems. In this hands-on role, you will be a technology expert and IT system owner for Veeva clinical and regulatory platforms. Key responsibilities include leading implementations, supporting systems, collaborating with stakeholders and vendors, and ensuring system validations. You will act as a subject matter expert for R&D, clinical, regulatory, and quality functions. The position requires extensive experience in clinical and regulatory systems within the life sciences industry, along with proficiency in Veeva applications and various technologies. A hybrid work environment is offered, with a preference for onsite/hybrid candidates. Competitive compensation and comprehensive benefits are provided.

Requirements

• Bachelor’s degree in computer science, Information Systems, Engineering, Quality, Regulatory, or Business, with 12+ years of relevant IT experience
• 7+ years of relevant experience in architecting, implementing and supporting clinical and regulatory systems in a life sciences and pharma industry
• Experience with business processes and System Development Lifecycle (SDLC) in a GxP regulated environment is a must
• 5+ years of relevant experience with implementing and supporting clinical and regulatory systems
• Strong knowledge and hands on experience implementing Electronic Data Capture EDC and other clinical platforms and data management solutions, preferably with Veeva EDC and clinical platforms
• Proficiency in configuring and maintaining Veeva vault applications
• Strong knowledge in Regulatory operations and hands on experience implementing and supporting Regulatory management systems preferably Veeva Vault RIM system
• Good knowledge and experience in building and managing Cloud environments and building clinical data warehouse and visualization and dashboards using tools such as Spotfire, Tableau or PowerBI
• Good understanding of technologies such as SQL, SOQL, REST, SOAP, HTML5, JavaScript, Python or R and supporting statistical tools such as Minitab and JMP
• Stay updated on new technologies and trends, ensuring the company derives optimal value from both current and prospective solutions or technologies under consideration for adoption
• Familiar with waterfall and/or Agile project management methodologies
• Very good communication and problem-solving skills
• Self-starter: able to work independently, proactively identify challenges, and be accountable
• Experience in leading multiple vendors such as software providers, system integrators and managed services partner on projects and support

Responsibilities

• Act as a subject matter expert and application lead for R&D, clinical, regulatory and quality business functions in biopharmaceutical environment
• Lead and own IT roadmap and implementations for Clinical and Regulatory teams and be hands on technical expert with solution design, system configurations, testing and validation
• Perform requirement gathering, risk assessment, impact assessment of new and existing systems
• Collaborate with business stakeholders, IT and external vendors to prioritize and implement new business capabilities and provide day-to-day operations support for clinical and regulatory systems
• Work with business stakeholders, vendors and quality teams to lead the implementation of Veeva clinical systems such as Vault EDC, CDB, RTSM and Veeva Vault RIM platform for regulatory function. Act as the IT system owner for these platforms
• Collaborate with quality team and external vendors on GxP systems operations, Change management, CAPAs and computerized systems validation
• Lead requirement gathering, solution design and user acceptance testing of system changes to ensure quality production deployments
• Lead the implementation and support of Clinical data analytics solutions
• Review and own IT activities for change control requests and provide all required documentations for clinical systems
• Assist clinical team with data management, migration, and analytics for study related data in EDC
• Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness
• Develop, review and update standard operating procedures (SOPs) and policies related to GxP systems

Preferred Qualifications

• Certifications in Veeva EDC, RIM will be a plus
• Experience in implementing other clinical systems such as eTMF, CTMS and Payments solutions will be a plus

Benefits

• Hybrid work environment
• Health, dental and vision insurance benefits
• Generous paid time off, including vacation, holidays, and personal days
• Bonus
• Stock equity