Director of Clinical Research (MD) - Inflammation / Respiratory
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POST DATE 9/10/2016
END DATE 1/13/2017
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
* The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide.
* The successful candidate will have oversight for ongoing and planned product trials within the inflammation therapeutic area.
* The Clinical Research MD will report to a more senior member of the inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
ESSENTIAL DUTIES AND JOB FUNCTIONS
* Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials.
* Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
* Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
* Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
* Coordinates the collection and analysis of clinical data for internal analysis and review.
* Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
* Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
* Develops manuscripts for publication in peer-reviewed journals.
* Will be part of a team responsible for defending the clinical development program before regulatory authorities.
* Serves as a scientific and clinical resource within Gilead Clinical Research
* Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
* Assists in the clinical evaluation of business development opportunities.
KNOWLEDGE, EXPERIENCE AND SKILLS
MD or equivalent.
* Three (3) to five (5) years experience with a proven success record in clinical research studies and trial design is required.
* Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.
* Experience in inflammation drug development.
* Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
* Strong leadership skills with an ability to set vision, lead change, and mentor others.
* 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.
* Excellent scientific written and oral communication skills.
* Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
* 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.
* Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected).
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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