Job description
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Job Description
Associate Director, Clinical Development
You will typically lead multiple components of clinical trial programs in pediatric oncology clinical development. For the assigned projects, you are accountable or 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, and clinical development inputs into regulatory documentation, publications and scientific presentations.
Responsibilities:
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Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
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Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
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Provides input into, or otherwise leads, pediatric study plans, clinical trial protocol design, clinical study reports and health authority inquiries.
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Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
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Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
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Coordinates the collection and assimilation of ongoing data for internal analysis and review.
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Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
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Presents scientific information at scientific conferences as well as clinical study investigator meetings.
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Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Education & Experience:
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Relevant years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
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Board certification in Oncology is preferred, including familiarity with pediatric oncology.
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Experience in the biopharma industry is preferred.
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Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
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Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
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Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
Knowledge & Other Requirements:
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Proven analytical abilities as demonstrated through past experience and/or academic research.
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Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
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Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
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Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
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When needed, ability to travel.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
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