Associate Director, Connect Process

Associate Director, Connect Process
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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.

Job Description

The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director, Connect Process supports process analysis and documentation for the Clinical Operations organization within a fast-paced and highly regulated environment. In addition, they may have multi-project responsibilities and serve as a project manager as needed on complex initiatives and working groups.

Job Description:
Drives assigned initiatives/projects and working groups ensuring progression to achieve timelines.Oversees Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts.In collaboration with R&D Quality's Process, Documentation & Learning team, provides expert direction to teams to business process owners, cross cross-functional stakeholders, and subject matter expertsPerforms content review and quality control for a portfolio of documents ensuring alignment with Gilead policies, procedures, and best practicesProposes and implements plans to resolve organizational process issues and execute process-related corrective actions resulting from inspections/auditsDetermines actions required to achieve team goals and leverage junior staff accordingly and manage junior staff and develop their capabilities in alignment with organizational prioritiesSynthesizes operational/performance/compliance data and present business cases clearly to initiative review committee(s)Collaborates with key stakeholders to assess process alignment and prioritize revisions as necessary to ensure continued relevance and applicability of processes and associated procedural documentsCollaborates with Clinical Operations and/or Development change management leads to ensure appropriate change management strategies are defined and executedCollaborates with Connect Learning and advises on the development and delivery of training Collaborates with Connect Quality and implements process changes resulting from audits/inspectionsDrives standardization and the adoption of best practices across the Clinical Operations organizationEnsures Clinical Operations processes and associated procedural documents are aligned with industry and regulatory expectations/regulations (i.e. 21 CFR, ICH E6 (R2))Leads and supports efforts to increase compliance awareness, a culture of compliance and inspection readiness

Required Knowledge/Skills:

Project Management Fundamentals
Navigates projects amidst ambiguous situations and changing prioritiesManages multiple projects while monitoring quality work product from self and teamAligns stakeholders, manages project scope, and drives teams to achieving timelines
Core Technical Skills
Analyzes problems and logically structure problem-solving strategies to resolve identified/anticipatedThorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studiesFluency with Microsoft Office suite, including MS Visio and ProjectStrong interpersonal and negotiation skillsAwareness of change management strategies being implemented across cross-functional teamsSynthesizes inputs from various stakeholders into coherent deliverables and outputsCollaborates flexibly with virtual and remote team members and colleaguesDirects multiple projects in alignment with overall business objectivesCommunicates complex datasets and findings to relevant stakeholders
Interpersonal Skills
Strong change champion with a good understanding of change management strategiesStrong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.

Education & Experience
10+ years of relevant experience with a Bachelor's degree8+ years of relevant experience with a Master's degreeIncludes 10 years of management of project management or process improvement teams

The salary range for this position is: $191, $247, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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