Senior Clinical Trials Manager

职位描述

Position Overview

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.

Basic Qualifications

• PhD/PharmD and 0+ years of relevant experience; OR

• MA/MS/MBA and 4+ years of relevant experience; OR

• BA/BS and 6+ years of relevant experience

• Prior clinical trials/operations experience in company sponsored clinical trials

Preferred Qualifications

• Proficient in Excel and use of data to drive data-driven strategies and decision making, and to create data analytics/visualizations.

• 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

• Prior oncology clinical trials experience