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Gilead Sciences

Makes medicines for HIV, liver disease and cancer

Manager – Medical Affairs

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeFoster City, CA, USA

About the Job

Requirements

  • Six or more years of experience with a bachelor's degree, or four or more years of experience with a master's degree.
  • Knowledge of regulatory and legal requirements for clinical trials and other Medical Affairs activities, including FDA regulations, ICH guidelines, and GCPs governing clinical trials.
  • Project management and organizational skills, including process improvement and management of multiple resources and priority projects with tight timelines while maintaining attention to detail.
  • Ability to work in a global environment and participate in meetings outside standard work hours to accommodate time zone differences.
  • Ability to interact appropriately within Medical Affairs and across Development, senior management, and external customers and vendors.
  • Interpersonal, written, and verbal communication skills.
  • Track record of executing defined goals and objectives in a fast-paced environment.
  • Ability to work independently and as part of teams.
  • Ability to engage and manage multiple stakeholders to achieve objectives.

Responsibilities

  • Manage review of investigator-initiated, collaborative, and Gilead-sponsored proposals through the Research Committee review process for HIV Prevention.
  • Coordinate proposal review meetings with Research Committee Team Leads and Chairs.
  • Support creation and management of requests for proposals.
  • Support external investigators, scientific leads, Medical Scientists, and other stakeholders in developing and submitting research proposals to Gilead.
  • Support management of the HIV Prevention Phase 4 portfolio, including liaison with Clinical Operations, local affiliates, and external investigators.
  • May review abstracts and manuscripts resulting from the Phase 4 program.
  • Help ensure research processes and study execution align with Medical Affairs research policy and governance, integrated evidence plan priorities, and overall program strategy.
  • Work with the Senior Manager to track, monitor, and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies that are 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, anticipate and resolve obstacles collaboratively, and engage in project management activities as assigned by the Research Committee Team Lead or Senior Manager.
  • Create inclusion by demonstrating the business value of diverse and inclusive teams and embedding equity and respect into day-to-day people management practices.
  • Develop talent by understanding team members’ skills, experience, aspirations, and potential, and providing coaching, feedback, and development opportunities.
  • Empower teams by connecting team goals to organizational purpose, removing barriers to execution, and enabling cross-functional collaboration.

Desired Qualifications

  • Professional degree such as a PhD or PharmD; alternatively, a master's degree such as an MS or MPH with four or more years of clinical or observational research experience, including research operations; or a bachelor's degree with six or more years of experience.
  • Understanding or experience in Medical Affairs or the pharmaceutical industry in Phase 4 or externally sponsored research programs, or Clinical Development.
  • Scientific knowledge or experience in HIV.

About the Company

Gilead Sciences

Makes medicines for HIV, liver disease and cancer

Gilead Sciences is a biopharmaceutical company that discovers, develops and sells medicines for HIV, viral hepatitis and other liver diseases, cancer and inflammatory conditions. Its HIV business covers both treatment, led by the once-daily pill Biktarvy, and prevention, including Descovy and Yeztugo, a lenacapavir injection given twice a year. In cancer, its Kite unit makes CAR T-cell therapies from patients' own immune cells, and Trodelvy is an antibody-drug conjugate for breast cancer. Gilead earns revenue by selling its drugs to wholesalers, specialty pharmacies, hospitals and governments worldwide after regulatory approval. The company was founded in 1987 and is headquartered in Foster City, California.

Company size
10,001+
Company stage
IPO
Headquarters
Foster City, CA
Founded
1987

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