The Manager, R&D IT will work closely with IT and members of the Research and Development organization to identify and deliver technology solutions that meet current and future needs of the organization. This role requires strong business analysis and collaboration skills, and a deep knowledge of business process and applications within Life Science’s Research and Development, primarily Quality Assurance, Regulatory Affairs/Operations, and Pharmacovigilance. This individual will work closely with R&D leadership to understand business goals, objectives and operations, and develop IT strategy to meet the needs of the business. This role will collaborate with solution vendors, SDP IT Infrastructure and SDP Quality Assurance as necessary for implementation and other services.
- Collaborate with RD and IT leadership to ensure a thorough understanding of the prioritization, scope, schedule, budget, and compliance needs of each IT-related project/program.
- Collaborate with R+D business functions (i.e. Biostatistics, Development, RA/QA, Drug Safety, Medical Affairs and CMC/Supply Chain), IT Infrastructure, QA and partners to identify IT solutions to meet current and future business needs, scope, solutions, constraints, and risks.
- Primary focus will be those functions with regulatory reporting requirements including Quality Assurance, Regulatory Affairs/Operations and Pharmacovigilance.
- Maintain the validated state of IT R&D applications to ensure compliance to global regulatory standards.
- Maintain productive relationships with parent company, internal/external partners and relevant affiliates/subsidiary/s.
- Bring awareness of new technology and products to the business, support business reengineering as needed
- Act as Project manager to lead the execution of IT project implementations and upgrades as needed.
- May select, manage and coach R&D IT Business Analysts.
- Perform other duties as assigned.
- Bachelor or Advanced Graduate degree(s) in Information Technology/business solutions or general business or life sciences.
- Professional experience (8+ years) in various R&D IT or similar technical roles of increased responsibility.
- Experience in pharmaceutical/biotechnology and deep understanding of regulations (Good Clinical Practice, 21 CFR Part 11).
- Experience with industry standard solutions including Veeva Vault (RIMS), Master Control, Argus, and other comparable solutions.
- Strong interpersonal skills, with demonstrated ability to work in a collaborative, multi-disciplinary setting, foster and nurture teamwork, and act as a facilitator to drive fulfillment of IT and corporate strategic goals.
- Ability to communicate up and down the management chain, providing the appropriate level of detail and focus on the right information.
- Experience delivering technical solutions across multiple business groups.
- Experience with SaaS, PaaS models and managed services
- Strong written and verbal communication skills
- Self-directed, within the framework of IT and corporate policies, and possessing the ability to thrive in a small company environment, working independently and/or with small teams, and with limited support
- Analytical thinker, with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Job Location: Cambridge, MA
Equal Opportunity Employer
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