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Senior Director, Clinical Development- Inflammation/Fibrosis (MD)

United States – Remote, United States - Washington - SeattleClinical Development & Clinical OperationsRegular

Job Description

Essential Duties and Job Functions:
* 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, with eight (8)+ years industry 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 oncology 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).