Director, R&D Information Systems

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.

Cambridge or Stockley Park , onsite 3 days a week.

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, liaison 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.

• Oversees or otherwise leads specific projects and /or acts 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.

• 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.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together., Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.