Associate Director, IT - Cambridge, MA
Sarepta Therapeutics is focused on developing first-in-class RNA-based therapeutics to improve and save the lives of people affected by serious and life-threatening rare and infectious diseases. The Company’s diverse pipeline includes its lead program eteplirsen, for Duchenne muscular dystrophy, as well as potential treatments for some of the world’s most lethal infectious diseases. Sarepta aims to build a leading, independent biotech company dedicated to translating its RNA-based science into transformational therapeutics for patients who face significant unmet medical needs. For more information, please visit us at www.sareptatherapeutics.com.
Provide overall technical and operational leadership and manage the portfolio of IT infrastructure, business application systems, personal computing and related systems for Business Functions including: Commercial, Corporate Quality & Regulatory, Clinical Development, Biostatistics & Data Management, Medical Affairs, Manufacturing, Finance and Administration, and other departments in a regulated environment. Partner with IT staff, business owners and project sponsors to identify and solve business problems. Conduct strategic assessments, valueproposition analysis and design and map business functions. Design, configure and deliver custom or in-house applications for Commercial, G&A and R&D organizations. Maintain high levels of performance and uptime for existing IT infrastructure as well as develop the strategies for new IT infrastructure and manage the implementation of the infrastructure. Position reports to Chief Financial Officer.
Primary responsibilities include:
- Work with the CFO, IT and Project Management function and manage the portfolio of business applications and IT infrastructure at Sarepta.
- Direct and perform the business analysis and design for IT applications for Sarepta business functions. Meet with customers and business teams to determine needs and develop solutions.
- Lead and direct the planning, coordinating, and scheduling of investigations, feasibility studies, surveys, vendor audits and technical evaluations/decisions on IT strategies.
- Work with other IT team members and provide advanced mission critical applications support for internal customer organizations. Manage these applications, systems interfaces and the associated infrastructure.
- Plan and coordinate the analysis, design, programming, timely implementation, validation and testing of applications and infrastructure projects. Review design, analysis, and configurations for quality and adherence to standards.
- Direct the implementation of solutions in accordance with GxP practices, FDA 21 CFR Part 11, SOX404 regulations and Sarepta SOPs as it pertains to Information Systems.
- Prepare and deliver presentations to senior management.
- Implement established policies, system monitors and controls to ensure successful management and reporting of all IT corporate initiatives.
- Lead and direct the IT systems and support teams
- Establish and manage IT department budget
- IT vendor management and negotiations
Education and Skills Requirements:
- Bachelors Degree in Information Systems or related area; 12 years of related experience including at least 5 years of IT management and project management with large scale projects to include, data center migration, virtualizing physical infrastructure, distributed storage solutions, finance system migrations and developing Application Systems in GxP-regulated environment. MBA or MIS is desirable.
- Demonstrated ability to direct and manage cross-functional teams and direct high quality IT projects. Proven experience acting independently and leading at an advanced level of technical expertise.
- Business Analysis experience with large systems in a cloud environment or in-house platform is required.
- Comprehensive knowledge of several systems such as EDMS, EVMS, , SAS, MDM, SFA, LMS, Dynamics GP, HRIS, and enterprise financial and expense reporting. Knowledge of current technological developments in areas of expertise.
- Demonstrated skills in fostering a cooperative work environment and negotiating and resolving conflict with colleagues. Personal preference to engage in timely, high quality exchange with others.
- Prior experience planning, designing, coordinating the installation, test, and modification of complex systems.
- Excellent written and verbal communication skills are essential: demonstrated skill expressing oneself in groups and one-on-one and conveying information clearly in writing; skilled in preparing and delivering presentations.
- Working understanding of GxP and FDA 21 CFR Part 11 and SOX404 regulations related to Information Systems and extensive experience working with Quality Assurance is required.
- Proven ability to interpret client information needs and determine appropriate alternate solutions.
- Proven ability to perform effectively under conditions such as project changes, tight deadlines and limited resources.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.