Senior Manager R&D IT Research and Development

Job Description

The R&D IT Capability Manager will be responsible for business stakeholder management, business demand management and for supporting the R&D IT technology portfolio by working closely with Capability managers, Portfolio Managers, PMO and the business stakeholders.This role will take accountability and ownership of stakeholder management, demand management and will work closely with R&D IT delivery team to deliver the technology roadmap projects.Client DetailsClient is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19DescriptionFunctional Job Responsibilities:

• Is responsible for International R&D IT stakeholder management (ACE, IC/GPS affiliates), budget (Financial Cycle Planning and estimate), and to support the portfolio/programs/project financial management. This role will strengthen IT coreoperations across the affiliates to ensure stable, secure systems/solutions that optimize efficiency to enable and drive the business demands and needs.
• Capability and capacity based financial planning for R&D IT technology investment projects, sustainment and operational activities for Regulatory Affairs focusing on document management, promotional materials review, archiving and translationcapabilities. This role will be responsible for working with business team to deliver best in-class and innovative solutions for business capabilities, partnering with our R&D IT technical team.
• Act as single point of contact for PMs across R&D IT projects/programs/portfolio focusing on International requirements to ensure strict compliance of processes, standards, and timelines to enable strategic partners to deliver businessvalue.
• Expert level knowledge of enterprise demand management lifecycle from demand intake to execution across Agile and waterfall methodologies using continuous improvement methodologies.
• Expert level hands on knowledge in process improvements across the portfolio in terms of yearly planning cycles, project submission requests based on organizational submission cadence.
• Is responsible for Inspection Readiness - global inspections and internal/external audits from R&D IT team, designing an inspection playbook and working closely with Regulatory Compliance team, Infrastructure IT team and R&D IT team SMEsfor alignment and resource planning across all functional domains within R&D IT for HA inspections, audits, inspection summary, and IT actions.
• Is responsible as Business Engagement lead for global Gilead Mergers, Acquisitions, and collaborations from R&D IT perspective, working closely with senior IT and business management, IT infrastructure, security, and M&A team to plan, collaborateand execute a smooth onboarding of new personnel, systems, and processes as appropriate.
• Travel to Gilead affiliates in order to meet the business stakeholders and IT team in-person for strategic planning, stakeholder management and technology roadmap projects as required.

ProfileBasic Qualifications:

• Bachelors Degree and Significant Experience OR Masters Degree and substantial Experience.
• Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred.
• Good understanding of GxP compliance and 21 CFR Part 11 requirements.
• Expert level expertise in R&D (Regulatory Affairs) domain - business and technology processes, GxP change management, VeeVa RIM, PromoMats suite, submissions planning, registrations, archiving and document management systems.
• Expert level expertise in Lorenz docuBridge, Insight suite, AWS, MS Project or similar, Azure Dev/Ops and RPA (Robotic Process Automation) as a welcomed addition.
• Hands on expertise in Agile/Scrum/Waterfall planning and execution of portfolios across all demands and request life cycles.

Preferred Qualifications:

• Significant Capability Management/Business Engagement experience within R&D IT landscape
• Experience in general pharmaceutical R&D area business processes covering Regulatory Affairs.
• Hands on work experience within IT industry
• Experience in business/industry (beyond Pharma), managing cross-functional portfolios/programs/projects
• Excellent interpersonal skills.
• Experience in GxP applications (and Good Documentation Practices).
• Experience working with SaaS applications and monitoring service levels and deployment schedules.
• PMO Certification - Six Sigma, PMP, APMP or similar is highly preferred but not mandatory.
• Has domain expertise in managing IT budget preferably within R&D IT across capabilities within the function
• Demonstrated customer focus, vendor management and negotiation skills with external vendors, their PMs and resources to keep everyone in line to financial roadmaps and targets

Job OfferOpportunity to join a global biopharmaceutical company2 days a week office requirement (Cambridge)Really strong compensation packageClient is embarking on loads of transformation projects

Keyskills :
GxPPharmaLifescience21 CFRR&D (Research and development)Highly regulated environmentsVeeVa RIMLorenz