Director, R&D Information Systems in Cambridge

Gilead Sciences is creating a healthier world for all people. For more than 35 years, we have tackled diseases such as HIV, viral hepatitis, COVID‐19 and cancer – working relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.

As a Director in the Regulatory and R&D Quality Systems organization, you are a thought leader and partner for Regulatory Affairs and R&D Quality stakeholders focusing primarily on regions outside of the U.S. to bring visibility into requirements that will directly support business processes and users in those regions. It requires a good understanding of current technology trends with a keen eye on innovation to help drive change in how technology can continue to transform and support the business in meeting key corporate objectives.

Main Responsibilities

• Provide expertise, guidance, and leadership in Regulatory Information Management (RIM), Submission Management, Inspection Readiness and AI technologies while applying an enterprise mindset.
• Manage escalations during critical system issues/outages, liaise with IT and Business to ensure impact is clear and support timely communication to end users through resolution.
• Operate as a representative for Development Systems during inspections and audits, as applicable.
• Mentor and guide other Development Systems team members in the U.K. on cross‐functional projects.
• Work with the team and leaders across geographic regions to ensure support and functional needs are met.
• Serve as primary driver and knowledge resource within the team on system evaluation of new or improving technologies to more efficiently meet changing business needs.
• Serve as subject matter expert on cross‐functional requirement gathering, and implementation teams.
• Provide strong leadership and engagement with senior leaders, internal and external partners and stakeholders.
• Provide strategic input to future planning and development of the Development Systems Department.
• Oversee or otherwise lead specific projects and/or act as a core project team member.
• Interact frequently with other functional areas (i.e., Regulatory Affairs, R&D Quality, Patient Safety, IT).
• Represent Development Systems as a technical subject matter expert and contact for projects.

Requirements

• BA or BS degree in a scientific discipline, information systems or equivalent, with a 12+ years managing Regulatory Affairs systems or related experience, or a MS degree in a scientific discipline, information systems or equivalent, with 10+ years managing Regulatory Affairs systems or related experience.
• Proven track record of driving change and strengthening capabilities in complex, multi‐functional organizations by introducing new technologies and processes.
• Works with minimal direction and exercises latitude in determining technical or business objectives of assignments.
• Solid understanding of change management methodology and execution.
• In‐depth experience in Regulatory Information Management technologies and how the industry is transforming with AI and other innovative technologies.
• Good understanding of computer system validation methodology, development, and execution.
• Extensive relevant experience in the pharmaceutical/biotechnology industry including both global and regional roles, particularly in Regulatory Affairs and/or R&D Quality.
• Highly driven self‐starter, taking personal ownership and initiative, with an ability to navigate through ambiguity; exhibit resourcefulness and provide prioritization and focus.
• Exhibit solid leadership skills with an ability to set a clear vision, goals and objectives to inspire and drive innovative thinking and influence across functions.
• Experience working with cross‐functional teams is required.
• Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.
• Demonstrated experience organizing ad hoc teams to achieve accelerated results.
• Excellent planning and organizational skills. Persuasive writer with strong verbal communication skills.
• Demonstrated ability to apply technical knowledge to oversight, troubleshooting, and training.