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Gilead Sciences

Makes medicines for HIV, liver disease and cancer

Director – Clinical Development

Biology & BiotechConfirmed live in the last 24 hours
Full-timeFoster City, CA, USA

About the Job

Requirements

  • An MD and four years of experience are required.
  • Clinical, scientific, or drug development experience in biopharma, healthcare, consulting, academia, or a related environment is required; biopharma experience and clinical experience in medical monitoring are preferred.
  • Experience working on and leading cross-functional project or program teams in life sciences, healthcare, consulting, or academia is required.
  • Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications, and presentations is required.
  • Experience presenting scientific or clinical data through publications, abstracts, posters, presentations, or other scholarly activities is preferred.
  • Experience collaborating across multidisciplinary teams in academic, clinical, research, or industry settings is preferred.
  • Training or experience in Infectious Diseases, Immunology, Pulmonology, or a related medical specialty, and familiarity with emerging viruses or pandemic preparedness, are preferred.
  • Complex project management skills and the ability to manage multiple clinical project deliverables and priorities through matrix management and leadership are required.
  • The ability to learn quickly and apply new concepts in a fast-paced environment is required.
  • Flexibility and adaptability, including the ability to manage multiple priorities and contribute across projects, are required.
  • Strong analytical and critical thinking skills, demonstrated through clinical practice, research, academic training, or other professional experience, are required.
  • A foundational understanding of the drug development process and clinical research, or a strong interest and aptitude for learning these areas, is required.
  • Understanding of FDA and EMA regulations, ICH guidelines, Good Clinical Practice, and standard clinical research principles is preferred but not required.
  • Strong scientific and medical knowledge, including the ability to critically evaluate and interpret clinical and scientific data, is required.
  • Excellent communication, presentation, organizational, and interpersonal skills are required.
  • The ability to work effectively in a collaborative, cross-functional environment is required.
  • Willingness and ability to travel as needed is required.

Responsibilities

  • Lead or contribute to multiple aspects of clinical development programs within the Virology Therapeutic Area, typically leading one or more components of programs, including Respiratory/Emerging Viruses.
  • Own assigned clinical trial program activities, including study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, clinical development inputs into regulatory documentation, publications, scientific presentations, pandemic preparedness, and outbreak responses to emerging viruses.
  • Provide scientific and clinical expertise to cross-functional teams to support clinical development project deliverables and timelines, including work on Respiratory/Emerging Viruses and pandemic preparedness or emerging outbreak responses.
  • Contribute to the development and review of clinical trial protocols, clinical study reports, and responses to health authority inquiries.
  • Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Contribute clinical development components to the preparation and review of regulatory documents, investigator brochures, and development plans.
  • Support the collection, review, and interpretation of clinical data for internal analysis and decision-making.
  • Manage the preparation or review of data listings, summary tables, study results, and scientific presentations.
  • Present scientific and clinical information at investigator meetings, internal forums, and scientific conferences.
  • Adhere to regulatory requirements for study conduct, industry standards of Good Clinical Practice, and Gilead standard operating procedures.
  • Create an inclusive team environment and embed the value of diversity in team management.
  • Understand employees’ skills, experience, aspirations, and potential; coach them on performance and future potential; and ensure they receive feedback and insight to support development.
  • Align team goals, purpose, and organizational objectives, hold the team accountable, remove barriers, and connect the team to the broader organization.

Desired Qualifications

  • Clinical experience in medical monitoring and experience in the biopharma industry.
  • Training or experience in Infectious Diseases, Immunology, Pulmonology, or a related medical specialty, and familiarity with emerging viruses or pandemic preparedness.
  • Experience presenting scientific or clinical data through publications, abstracts, posters, presentations, or other scholarly activities.
  • Experience collaborating across multidisciplinary teams in academic, clinical, research, or industry settings.
  • Understanding of FDA and EMA regulations, ICH guidelines, Good Clinical Practice, and standard clinical research principles.

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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