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
We are seeking a Manager within Phase 4 Research to support HIV Treatment within Global Medical Affairs. This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led Gilead-sponsored research in HIV Treatment. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of one or more of relevant therapeutic areas.
This position is based at Gilead’s Foster City, CA location.
Specific Job Responsibilities:
Manage the review of ISR, CO and MA-led GS proposals through Gilead’s Research Committee (RC) review process for HIV Treatment:
Coordinate proposal review meetings with RC Team Leads and RC Chairs
Support creation and management of requests for proposals (RFPs)
Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Gilead
Support the management of the HIV Treatment Phase 4 portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators
May review abstracts and/or manuscripts that result from the phase 4 program
Contribute to ensuring that the research processes and study execution align with MA research policy and governance, integrated evidence plan priorities, and overall program strategy
Work with Senior Manager to track, monitor and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies when not meeting contracted milestones
Act as a resource for Research Committee Chairs, voting members, standing members, proposal champions and reviewers
Contribute to process improvements related to research proposal and study management systems
Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and engage in project management activities as needed by assigned RC Team Lead and/or Senior Manager
Basic Qualifications:
High School Degree and Eleven Year's Experience
OR
Associates Degree and Nine Years Experience
OR
Bachelor's Degree and Seven Years’ Experience
OR
Masters' Degree and Five Years’ Experience
Preferred Qualifications:
Professional degree (eg, PhD, PharmD); OR master’s degree (eg, MS, MPH) with 4-plus years of experience in clinical or observational research including research operations; OR Bachelor’s degree with 6-plus years of experience
Must be cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials
Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail
Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences
Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors
Excellent interpersonal, written, and verbal communication skills
Proven track record of executing clearly defined goals and objectives in a fast-paced environment
Self-motivated to work independently and having a positive attitude while working as part of teams
Ability to engage and manage multiple stakeholders to achieve the objective
Understanding/experience in in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
Scientific knowledge/experience one or more of the relevant therapeutic areas
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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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