Experience Inc. Jobs

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

Director, RWE Observational Research Operations

Located in Foster City, CA

Additional Locations:

Parsippany, NJ | Seattle, WA | Morris Plains, NJ | Raleigh, NC | Stockley Park, UK | Dublin, Ireland

Leveraging strong organization skills and clinical research operations background, the RWE Observational Research Operations Director plays an integral part in audit readiness through operational management and oversight of observational research studies and observational analyses within the Gilead Clinical Data Science Real-World Evidence (CDS-RWE) function. This role reports to the head of CDS-RWE Generation. The Director will lead efforts to ensure implementation and timely tracking of observational study milestones and deliverables. This role will be responsible for definition and implementation of metrics that monitor end-to-end observational research related activities and ensure audit readiness. This role is responsible to monitor trends, identify areas of improvement and collaborate with observational study stakeholders to continually improve processes for observational study conduct, quality, and compliance within the CDS-RWE function. This is a complex role and requires collaboration with observational research stakeholders within RWE and with other functions like Clinical Operations, Medical Affairs, GHEOR and Biomarker Sciences.. The successful candidate has experience in drug-development process, clinical study lifecycle, regulatory compliance, and the uses of real world evidence in clinical development and safety endeavors. They have demonstrated attention to detail, program and project management expertise, and the ability to thrive in a complex, fast paced, matrixed organization. Additionally, the ideal candidate will have the proven ability to effectively communicate to senior leaders of the organization.

Core Responsibilities

• As the lead individual responsible for operational tracking and audit readiness for observational studies within the RWE function:

• Accountable for ensuring that all studies led by the RWE function are audit ready and in compliance with local and national regulations and with Gilead procedural document

• Ensures study documentation are in compliance with all applicable regulatory requirements, industry standards, and Gilead internal policies throughout the conduct of RWE studies; ensures study-level audit readiness for CDS-RWE; assists with responses to process deviations and staff training

• Implement metrics to track quality and audit readiness of CDS-RWE deliverables

• Develops, implements and monitors processes for end-to-end tracking, e.g., from study initiation, study contracting, study conduct, study closeout. Supports budgeting, invoicing, and forecasting of study costs; Builds a team to support these efforts independently with almost no direct supervision.

• Build and lead capability to oversee observational study documentation including regulatory system management, trial master file, clinical trial management system (as needed) with almost no direct supervision.

• Oversee the management of external vendors and research partners involved in real-world evidence studies, including contract negotiation, performance monitoring, and budget management. Independently organizes the operations, planning and contracting with external partners.

• In conjunction with the CDS-RWE Therapeutic Area study leads, oversees the development of study timelines and tracks milestones to ensure deliverables are met; Track CDS-RWE initiatives and achievements over the year; Create metrices for tracking the status of NIS to support study update presentations leadership.

• Work closely with Head of CDS-RWE Generation and study leads to track evidence generation activities in the appropriate system(s); Oversees study operational support including tracking and reporting; as new tools are developed to support observational study conduct, leads implementation efforts

• Contribute to the strategic planning and execution of evidence generation initiatives to support product development, regulatory submissions, and market access activities

• Implements project to build capability within CDS-RWE and coordinates process improvement initiatives with stakeholders within RWE, CDS and across Development organizations

• Understands operational requirements and translates these into actions for quality and process improvement by interacting with employees and other teams

• Lead development of communications strategy and preparation/content including CDS-RWE process trainings and project/initiative presentations

• Lead some key RWE Generation initiatives with cross-functional partners

Capabilities and Requirements

• Exhibits expert knowledge related to the conduct of operational aspects of observational research, including observational studies and analysis. Understands key business processes and business areas. Acts as resource and provides direction to others. Has in-depth knowledge of the multidisciplinary functions involved in drug discovery and development and can proactively integrate multiple perspectives into research and/or development assignments.

• Strong organizational management skills, including attention to detail and cross-functional communication

• Implementation of program and/or portfolio management, tracking and dashboards

• Strong leadership and communication skills across functions; comfort in business and technical discussions. Able to influence without direct authority

• Proven leadership experience, with a track record of effectively managing teams and driving results in a matrixed organization.

• Expertise in administration of systems for study tracking and reporting

• Highly resourceful and strategic thinker with strong emotional intelligence and operational rigor

• Proven track record cross-functional collaboration withing a matrix organization and successfully managing complex, time-sensitive, transformational projects

• Proven track record of simultaneously managing multiple projects

• Previous administrative and organizational development experience in real world evidence or clinical research

• Expertise with processes and systems across RWE research disciplines, study, data and analysis lifecycles

• The ideal candidate will have demonstrated leadership in strategic planning and execution

• Experience driving large initiatives from framing the problem, conducting research / analysis to building the business and operational plans through to driving execution to success is required

• Self-starter who thrives in a fast-paced, collaborative, and innovative high-growth environment

• Limited travel

Education

• 12+ Years with BS, 10+ Years with MS/MBA, 8+ Years with PhD/PharmD, 4+ Years with MD

• Advanced degree in a scientific field relevant to RWE (e.g., epidemiology, public health, data science, clinical research) preferred

The salary range for this position is: $221,170.00 - $286,220.00. 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)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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.