
Director, Virology Clinical Development (MD)
United States - California - Foster CityClinical Development & Clinical OperationsRegularDescripción del trabajo
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 conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience:
MD or equivalent with clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
Board certification in Infectious Diseases is preferred, including familiarity with emerging viruses and/or pandemic preparedness.
Experience in the biopharma industry is preferred.
Experience working on and with cross-functional project / program teams in clinical research or development is preferred.
Experience supporting clinical study design, medical monitoring and regulatory filings.
Experience supporting clinical publications and presentations is preferred.
Knowledge & Other Requirements:
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Proven analytical abilities as demonstrated through past experience and/or academic research.
Understands drug development phases and the nature of associated clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
Has advanced knowledge of major disease areas, as evidenced by effectiveness supporting clinical projects.
Strong communication and organizational skills.
When needed, ability to travel.