Associate Director, Virology Clinical Development (MD)

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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Job Description
 

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 millions 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.

Associate Director, Virology Clinical Development (MD)

You will typically lead one or more components of the Emerging Viruses clinical programs in Virology clinical development. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, clinical development inputs into regulatory documentation, publications, and scientific presentations, pandemic preparedness, and outbreak responses to emerging viruses.

RESPONSIBILITIES:

Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.

Provides input into clinical trial protocol design, clinical study reports and health authority inquiries.

Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.

Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.

Coordinates the collection and assimilation of ongoing data for internal analysis and review, including but not limited to pandemic preparedness and/or emerging outbreak responses.

Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.

Presents scientific information at scientific conferences as well as clinical study investigator meetings.

Adheres to regulatory requirements of study condu