Job Description

About the Role:

We are seeking a Manager within Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products) to join our Global Medical Affairs Research team. This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led Client-sponsored research across LIVE. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area. This position is based at Client’s Foster City, CA location.

Responsibilities

• Assist in managing meetings for our LIVE Research Committee (RC).
• Manage reviews of ISRs, COs and MA-led Client proposals through the RC review process for:
• 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 Client
• Support the management of the LIVE portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators
• 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 the team 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, affiliates, 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

Qualifications

• Professional degree (eg, PhD, PharmD); OR master’s degree (eg, MS, MPH) with 2+ 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

Preferred Skills

• Understanding/experience in in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
• Scientific knowledge/experience in LIVE TAs

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