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