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Director Clinical Development HIV Prevention

United States - California - Foster CityClinical Development & Clinical OperationsRegular

Job Description

Director Clinical Development HIV Prevention

This is an opportunity to work in a dynamic role to support the clinical development of novel and innovative drugs for HIV infection.  This Clinical Research position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HIV medicine.  This role will primarily be involved in developing long-acting drugs for HIV prevention and may also support programs for HIV treatment and for HIV cure research. Working in collaboration with the HIV Prevention Program Lead, this position is responsible for various aspects of ongoing clinical trial program-related activities within the HIV therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of NDA/MAA/ROW filings.

Essential Duties and Job Functions:

  • Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
  • Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
  • Provides ongoing clinical medical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
  • Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
  • Coordinates the collection and assimilation of ongoing data for internal analysis and review.
  • Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
  • Presents scientific information clinical study investigator meetings, internal, and external meetings
  • Leads two or more specific components of cross-functional strategic initiatives.

Knowledge, Experience and Skills:

  • At least 4 years of relevant experience in clinical research in clinical drug development, in pharma, biotech, or academic clinical trials with an MD in relevant field.
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
  • Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
  • Excellent scientific written and oral communication and interpersonal skills are required.
  • Must be capable of working with attention to detail in a time sensitive environment.
  • Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is required.
  • Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job related programs such as Spotfire and RDMS
  • Ability to partner, influence and inspire others.
  • Ability to travel domestically and internationally once COVID19 restrictions are lifted to company, scientific, regulatory, investigator, and other meetings (~20% travel expected).

Desired Skills:

  • Familiarity with clinical virology and in particular HIV prevention and treatment  preferred
  • Direct experience in the strategic, and tactical implementation of drug development
  • Experienced with engaging internal and external expert physicians, scientists, and other key stakeholders, including community and civil society leaders, in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
  • Successful leadership and management experience
  • Experience in business development and assessment of opportunities is desired

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually, and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.