Director, Clinical Development (MD)

* Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.* Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.* Provides input into, or otherwise leads, 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.* 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.* MD or equivalent with 2+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.* Experience in phase 1 and 2 clinical trials is preferred.* Board certification in rheumatology/dermatology/gastroenterology or allergy and immunology is preferred, including familiarity with systemic autoimmune diseases.* Experience in the biopharma industry is preferred.* Experience leading small cross-functional project teams in clinical research or development.* Experience taking the lead on study concept and protocol design, regulatory filings, medical monitoring, clinical publications and presentations is preferred.* Proven effectiveness managing clinical project deliverables through matrix management.* 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. #J-18808-Ljbffr