Director, R&D Information Systems

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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.

Job Description

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.

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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.