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Gilead Sciences
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  • Associate Director, Regulatory Affairs, Oncology  

    - Cambridge
    Description  POSITION OVERVIEW: You will act as the Regional Regulator... Read More
    Description
     POSITION OVERVIEW: You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.RESPONSIBILITIES: As needed, represents Gilead in negotiations with regulatory authorities.Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.Defines the regulatory strategy for multiple Gilead products or projects.Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.Critically reviews documents for submission to regulatory authorities.Provides matrix management and leadership to project teams.Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Rest of World Education & Experience BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.Knowledge & Other Requirements In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.Strong interpersonal skills and understanding of team dynamics.Strong communication and organizational skills.Strong negotiation and conflict resolution skills.When needed, ability to travel.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 individual’s 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. Read Less
  • Associate Director, Commercial Excellence IT  

    - Uxbridge
    Description  Gilead Sciences, Inc. is a leading biopharmaceutical comp... Read More
    Description
     Gilead Sciences, Inc. is a leading biopharmaceutical company dedicated to advancing global health through scientific innovation. For over three decades, Gilead has been at the forefront of developing transformative therapies for life-threatening diseases, including HIV, viral hepatitis, and cancer. Headquartered in Foster City, California, Gilead operates in more than 35 countries worldwide.As part of our commitment to improving lives, we foster a collaborative and inclusive work environment where every individual is valued and empowered to contribute meaningfully. At Gilead, you will join a mission-driven team focused on discovering, developing, and delivering innovative therapeutics that make a real difference.We are seeking an experienced and visionary Associate Director, Commercial Excellence IT (Ex-US) to join our Commercial IT organization. This strategic role will serve as the Capability Lead for Commercial Excellence, supporting affiliates across Australia, Canada, Europe (ACE), Asia, and Latin America. The successful candidate will act as a trusted technology partner to the business, driving innovation and enabling key capabilities—primarily focusing on Customer Relationship Management (CRM) and Events Management.This role will collaborate closely with cross-functional teams including Global Commercial Operations, Marketing, Medical Affairs, Business Conduct, and IT. It will be instrumental in shaping and executing technology strategies from ideation through delivery, ensuring alignment with business objectives and maximizing value.The ideal candidate will bring deep technical expertise, a problem-solving mindset, and a forward-thinking approach to technology. This is a unique opportunity to play a pivotal role in shaping the future of commercial excellence at Gilead, contributing to our mission of creating a healthier world for all. Gilead is currently in the process of selecting its Next Generation Customer Relationship Management (CRM) solution, a strategic initiative aimed at transforming commercial capabilities across its global operations. This role will play a leading part in the implementation of the new CRM platform across all ex-US affiliates, ensuring alignment with business needs, innovation and driving operational excellence.Key Responsibilities: Serve as a strategic technology advisor to cross-functional business partners—including Commercial, Marketing, Medical Affairs, and Compliance—across ex-US affiliates, translating complex business priorities into scalable, high-impact technology solutions that drive measurable valueLead the end-to-end delivery of complex technology initiatives, from ideation and architecture through deployment and sustainment, ensuring alignment with enterprise strategy and business needs.Define and maintain the strategic roadmap for CRM and Events Management capabilities, collaborating with business stakeholders, product owners, and ecosystem teams such as Data & Analytics.Partnering with CRM and Events Management Capability Managers, serve as the focal point for IT within the Commercial Excellence ex-US, consolidating regional business needs into prioritized technology roadmaps and actionable delivery plansOversee the technical design, development, and implementation of integrated solutions, ensuring adherence to architectural standards, regulatory requirements, and delivery methodologies (Agile, Waterfall, Hybrid).Manage cross-functional teams and vendor partnerships to deliver new platforms and features with agility, velocity, and quality, while optimizing cost and operational efficiency.Evaluate and recommend new technologies and practices to enable innovation, competitive differentiation, and strategic capability enablement across the Commercial ecosystem.Guide solution architecture and delivery planning, ensuring appropriate project governance, resource allocation, and risk mitigation across multiple concurrent initiatives.Collaborate with sourcing and procurement teams on RFPs, vendor evaluations, contract readiness, and capability assessments, ensuring alignment with Gilead’s standards for quality, security, and compliance.Monitor industry trends in CRM, HCP engagement, and digital engagement platforms, translating insights into product strategies and adoption plans that drive measurable business value.Lead strategic planning and budgeting for Commercial IT portfolios, ensuring alignment with regional business strategies and global IT frameworks.Facilitate stakeholder engagement and change management, ensuring successful adoption of new technologies through training, communication, business change management and post-deployment optimization.Represent Commercial IT in governance forums, architecture reviews, and external briefings, advocating for scalable, standardized solutions that support global-to-local harmonization.Mentor and develop team members, fostering a culture of innovation, accountability, and continuous learning.Requirements:We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Basic Qualification Associates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years’ Experience OR Masters' Degree and Eight Years’ Experience OR PhD and Two Years’ Experience.​Preferred QualificationMinimum 5+ years’ experience in a similar role, ideally within commercial IT or life sciences, with a strong track record of delivering major programmes and managing cross-functional teams.Extensive experience with Veeva CRM and Veeva Events Management, with exposure to Vault Platform and the Salesforce ecosystem.Strong understanding of field force effectiveness and sales operations processes, with the ability to translate business needs into scalable IT solutions.Strategic IT planning experience, including development of technology roadmaps aligned with business goals and priorities.Experience delivering cross-functional and cross-geographical IT solutions, with comfort engaging senior leadership and business stakeholders across a matrixed organisation.Familiarity with SDLC methodologies, including Agile, Waterfall, Hybrid, and product-centric approaches, and experience applying DevOps principles and CI/CD practices.Experience with integration tools such as Informatica and AWS AppFlow, and a solid understanding of solution architecture and integration protocols.Proficiency in API technologies, including RESTful APIs and platforms such as Apigee, with the ability to lead teams in designing robust and secure integration architectures.Strong enterprise technology knowledge, including cloud computing (e.g., AWS), platform architecture, and system integration, with the ability to assess capabilities and limitations.Proven ability to manage Managed Service Providers and Systems Integrators, ensuring delivery quality, governance, and vendor accountability.Gilead Core Values:Integrity (Doing What’s Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)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 individual’s 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. Read Less

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