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 acr... more details
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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 development
- Leverage strategic and analytical expertise to implement new portfolio management analysis approaches, methods, tools, and capabilities
- Reporting on study status (enrollment, SSU, etc) to optimize and drive data-driven decision making
- Leads 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 objectives
- Potential 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 budget
- Demonstrates 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 complexity
- Working knowledge and experience with Word, PowerPoint and Excel
- Proficient in Excel and use of data to drive data-driven strategies and decision making, and to create data analytics/visualizations
- 7+Years with BA/BS/RN or 5+ Years with MA/MS/MBA/PharmD/PhD
- Prior clinical trials/operations experience in company sponsored clinical trials required
- Prior oncology clinical trials experience
The salary range for this position is: $154,020.00 - $199,320.00. 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.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
