Jobs for People with MS: National MS Society

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) 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 experts

• Performs content review and quality control for a portfolio of documents ensuring alignment with Gilead policies, procedures, and best practices

• Proposes and implements plans to resolve organizational process issues and execute process-related corrective actions resulting from inspections/audits

• Determines actions required to achieve team goals and leverage junior staff accordingly and manage junior staff and develop their capabilities in alignment with organizational priorities

• Synthesizes 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 documents

• Collaborates with Clinical Operations and/or Development change management leads to ensure appropriate change management strategies are defined and executed

• Collaborates with Connect Learning and advises on the development and delivery of training

• Collaborates with Connect Quality and implements process changes resulting from audits/inspections

• Drives standardization and the adoption of best practices across the Clinical Operations organization

• Ensures 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 priorities

• Manages multiple projects while monitoring quality work product from self and team

• Aligns stakeholders, manages project scope, and drives teams to achieving timelines

Core Technical Skills

• Analyzes problems and logically structure problem-solving strategies to resolve identified/anticipated

• Thorough 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 studies

• Fluency with Microsoft Office suite, including MS Visio and Project

• Strong interpersonal and negotiation skills

• Awareness of change management strategies being implemented across cross-functional teams

• Synthesizes inputs from various stakeholders into coherent deliverables and outputs

• Collaborates flexibly with virtual and remote team members and colleagues

• Directs multiple projects in alignment with overall business objectives

• Communicates complex datasets and findings to relevant stakeholders

Interpersonal Skills

• Strong change champion with a good understanding of change management strategies

• Strong 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 degree

• 8+ years of relevant experience with a Master’s degree

• Includes 10 years of management of project management or process improvement teams

The salary range for this position is: $191,335.00 - $247,610.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

For jobs in the United States:

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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.