Director, R&D Information Systems at Gilead Sciences

Cambridge, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

BA or BS degree in a scientific discipline, information systems or equivalent, with 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 operates

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
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

Skills

Regulatory Information Management

RIM

Submission Management

Inspection Readiness

AI technologies

Regulatory Affairs

R&D Quality Systems

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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