Manager, Medical Affairs
United States - California - Foster CityMedical AffairsRegularDescrizione del lavoro
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.
Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
We are seeking a Manager within Medical Affairs Research to support Liver, Inflammation, Respiratory Viruses, and Established Products (LIVE). This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative (CO) research, and MA-led Gilead-sponsored research in the LIVE therapeutic area. 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.
As a Manager, Medical Affairs at Gilead you will ...
Specific Job Responsibilities:
Manage the review of ISR, CO and MA-led GS proposals through Gilead’s Research Committee (RC) review process for LIVE:
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 LIVE Phase 4 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 Research Committee Team Leads and 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
Educational and other Requirements:
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
Preferred Qualifications:
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