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Sr. Clinical Trials Manager, Clinical Operations- Oncology

4 months ago


Foster City, California, United States Gilead Sciences, Inc. Full time
Sr. Clinical Trials Manager, Clinical Operations- Oncology
United States - California - Foster CityUnited States - Washington - Seattle

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

Clinical Operations Oncology is responsible for the worldwide execution of all Phase 1 through 3 clinical trials within the Oncology Therapeutic Area. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products.

Gilead has a rich pipeline of promising medicines across multiple indications in Oncology with numerous submissions and readouts planned through 2025. There are numerous pivotal registrational trials, a robust early-mid phase pipeline, and a myriad of partnerships, collaborations, and opt-ins that require executive leadership and oversight. Oncology is a highly competitive landscape and flawless execution will be paramount to success.

Example Responsibilities:
Responsible for identifying cross-study synergies to leverage efficiencies and optimize performance across study teams (systems and technology, study design, decentralization, team/stakeholder communication, etc)Partner with oncology leadership and cross-functional teams to define, build, lead, and drive strategic processes and portfolio analytics developmentLeverage strategic and analytical expertise to implement new portfolio management analysis approaches, methods, tools, and capabilitiesReporting on study status (enrollment, SSU, etc) to optimize and drive data-driven decision makingLeads and participates in moderately complex assignments that enable multiple functions and teams to achieve their clinical study objectives within targeted timelines and allocated resource levels.Collaborates with other functions on how to best achieve their clinical goals and objectivesPotential to serve as Oncology Subject Matter Expert on cross-functional initiatives to further optimize organizational reporting capabilities and systems Drives aspects of CRO oversight to ensure the overall program(s) is completed compliantly, on-time, within-budget and to the quality expected. Consistently models our Leadership Commitments and Values for others to follow.Has the managerial courage to speak-up when needed, and in a manner that moves the business and team forward.Gives constructive, fair, balanced, concise and actionable feedback.Takes accountability to ensure change is understood and implemented well.Effectively influences without authority.Ensure study delivery is on time, as per scope and compliance, and within the allocated budgetDemonstrates ability to think short- and long-term in devising appropriate project strategies and approaches to completing project deliverables.Coaches and guides less experienced team members in solving problems. Depending on business need, may manage Clinical Project Assistant/Clinical Trial Management Assistant/Sr. Clinical Trial Management Assistant

Knowledge
Has advanced knowledge of study management best practices and tools and has shown ability to apply these to improve project efficiencies and effectiveness.Has significant industry (ICH/GCP and FDA/EMA regulations) knowledge, including knowledge of drug development, and is able to flex own knowledge to work on studies of varying scope and complexityWorking knowledge and experience with Word, PowerPoint and ExcelProficient in Excel and use of data to drive data-driven strategies and decision making, and to create data analytics/visualizations7+Years with BA/BS/RN or 5+ Years with MA/MS/MBA/PharmD/PhDPrior clinical trials/operations experience in company sponsored clinical trials requiredPrior oncology clinical trials experience

The salary range for this position is: $154, $199, 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.

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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.

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