Senior Director R&D IT

The Role:

We are seeking a highly experienced and strategic-minded Senior Director of R&D IT to play a critical leadership role in ensuring the alignment of technology strategies with our Quality, Clinical, Regulatory, Medical, Safety and CMC functions within the organization. This position requires a seasoned professional with a deep understanding of both quality management systems and information technology, coupled with experience in pharmaceutical development and manufacturing processes. The role also involves overseeing the implementation and maintenance of IT systems that support quality assurance, clinical drug development, and CMC operations while ensuring compliance with regulatory requirements.

Key Responsibilities:

• As an IT Business Partner to the R&D organization, develop and execute the strategic vision for Quality, Clinical, Regulatory, Medical, Safety and CMC IT initiatives in alignment with organizational and functional goals.
• Collaborate with senior management to integrate IT solutions into and across functional groups.
• System ownership of the Veeva platform, as well as other GxP administrated systems.
• Oversee the selection, implementation, and maintenance of IT systems supporting quality, clinical, regulatory, medical, safety and CMC functions.
• Manage the IT resources administrating and developing our Veeva Vault Platform.
• Ensure the security, integrity, and availability of data by directing vendors to implement appropriate controls and best practices.
• Own the IT QMS and drive continuous improvement efforts to enhance IT systems' efficiency and effectiveness in supporting quality and compliance requirements.
• Evaluate emerging technologies and trends to identify opportunities for innovation and competitive advantage within R&D.
• Manage vendor relationships, contracts, and service level agreements.
• Lead organizational change management efforts related to the implementation of new systems or process improvements.
• Lead a team of IT professionals responsible for implementing and supporting quality, clinical, regulatory, medical, safety and CMC IT systems.
• Provide guidance, mentorship, and professional development opportunities to team members to foster a high-performance culture.

Requirements:

• Bachelor's degree in Information Technology, Computer Science, Business Administration, or related field. Master's degree preferred.
• Extensive experience (10+ years) in IT leadership roles driving strategy and implementing systems within the pharmaceutical or biotechnology industry. Experience in Start-ups a plus.
• In-depth knowledge of quality, clinical, regulatory, medical, and safety processes and systems, and CMC operations in a regulated environment.
• In-depth knowledge and extensive experience (5+ years) working with and managing Veeva Vault technology and associated solutions.
• Strong understanding of regulatory requirements and compliance standards relevant to pharmaceutical IT systems (e.g., 21 CFR Part 11, GAMP 5, GxP).
• Proven track record of successfully leading IT initiatives that support quality, clinical, regulatory, medical, safety, and manufacturing functions.
• Excellent leadership, communication, and interpersonal skills, with the ability to collaborate effectively across functional areas and influence stakeholders at all levels of the organization.
• Demonstrated ability to manage and develop high-performing teams in a dynamic and fast-paced environment.
• Strong analytical and problem-solving skills, with a focus on driving continuous improvement and innovation in IT solutions.
• Strong analytical and problem-solving skills, with the ability to translate business requirements into technical solutions.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required 10%