Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022.
The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility for infrastructure design, implementation and support, budget planning and management, and the management of vendors in support of this function. Specific responsibilities include, but are not limited to: • Provide management oversight of company Helpdesk, including providing internal support to staff • Develop Communication plans for Onboard/Offboarding of staff • Maintain oversight of IT and Cyber securities contracts, including updating and renewals • Provide an escalation path for the timely and effective resolution of major technical and building issues that could affect key business systems and function • Work with senior leaders to understand the future company directions and growth and implement strategies to ensure technical services align and assist in the company goals • Work in partnership with the Regulatory and QA leaders to ensure submission compilation systems and tools are always compliant. • Work in partnership with the clinical teams, providing input and guidance on the systems provided by CROs and other vendors • Establish and maintain productive relationships with vendors • Review processes and systems for efficiencies, while ensuring compliance with country-specific regulations and all departmental SOPs, and ensuring technology is audit-ready • Provide technical expertise to staff as needed • Assist in the development of technical and operation SOPs and other procedural guidance documents • Stay up to date with the latest trends, innovations and offerings related to technical IT equipment, processes, and management of IT systems
Education and Training
Bachelor’s degree in technology or health sciences • Minimum 15 years of technology experience in the pharmaceutical, biotechnology or CRO industries is required • Prior hands-on experience with clinical, regulatory, and marketing functions, especially submission of NDAs, health authority advisory committee meetings and health authority inspections