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Director, Clinical Research

Company: Gilead Sciences, Inc., Seattle
Location: Lynnwood
Posted on: September 18, 2020

Job Description:

Sr. Director, Clinical Research (MD) - Inflammation Company: Gilead Sciences, Inc.

Location: Seattle

Posted on: September 13, 2020

Job Description:

Sr. Director, Clinical Research (MD) - Inflammation UnitedStates - Washington - Seattle

For Current Gilead Employees and Contractors: The clinicalresearch physician will play a key role at all stages of clinicaldevelopment for product programs from the drug discovery stagethrough product registrations world-wide.

The successful candidate will have oversight for ongoing andplanned product trials within the inflammation therapeutic area,including disease targets related to ocular and respiratoryinflammation

The Clinical Research MD will report to a senior member of theinflammation clinical team, who has direct responsibility for theoverall research strategy and clinical and scientific developmentactivities.

Essential Duties and Job Functions:

Will be part of a team responsible for all scientific aspects ofconceptualizing and planning trials.

Will be part of a team responsible for the preparation/review ofregulatory 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 conductand industry standards of Good Clinical Practice.

Coordinates the collection and analysis of clinical data forinternal analysis and review.

Will be part of a team responsible for managing the preparationand/or review of data listings, summary tables, study results,study reports, and clinical NDA sections.

Prepares presentations for scientific conferences as well as forclinical study investigator meetings and expert advisorymeetings.

Develops manuscripts for publication in peer-reviewedjournals.

Will be part of a team responsible for defending the clinicaldevelopment program before regulatory authorities.

Serves as a scientific and clinical resource within GileadClinical Research

Provides scientific and clinical guidance to Biology,Toxicology, Clinical Trials Management, Biometrics, Global DrugSafety, Regulatory, and Project Management staff.

Assists in the clinical evaluation of business developmentopportunities.

Knowledge, Experience and Skills:

MD, DO or equivalent.

Three (3)+ years’ experience required in pharmaceutical industrywith a proven success record in clinical research studies, trialdesign, execution and oversight.

Experience in the design of study protocols, consent forms, casereport forms, database design, data analysis and the constructionof appropriate tables and figures

Relevant industrial or academic experience in clinical researchwith basic understanding of Good Clinical Practices; directexperience in the study recruitment and consent is highlydesirable.

Direct experience in the strategic, and tactical implementationof drug development

Experience in inflammation/rheumatology/autoimmunity drugdevelopment.

Ability to think analytically and strategically to formulate,develop, and execute clinical plans.

Strong leadership skills with an ability to set vision, leadchange, and mentor others.

Ability to work effectively in a multidisciplinary team tocultivate an inclusive environment of respectful, open, and honestdialogue and to foster a robust sharing of ideas and creativeproblem solving.

Excellent scientific written and oral communication skills.

Ability to partner, influence and inspire others.

Experienced with engaging internal and external experts inconstructive scientific and clinical dialog around study design,study conduct, and interpretation of clinical results.

Well-developed sense of integrity, strong work ethic, scrupulousattention to detail, clear ability to establish and maintaintimelines, and persistent commitment to ensuring a high level ofquality.

#LI-LK1

For jobs in the United States: As an equal opportunity employer,Gilead Sciences Inc. is committed to a diverse workforce.Employment decisions regarding recruitment and selection will bemade without discrimination based on race, color, religion,national origin, gender, age, sexual orientation, physical ormental disability, genetic information or characteristic,gender identity and expression, veteran status, or other non-jobrelated characteristics or other prohibited grounds specified inapplicable federal, state and local laws. In order to ensurereasonable accommodation for individuals protected by Section 503of the Rehabilitation Act of 1973, the Vietnam Era Veterans'Readjustment Act of 1974, and Title I of the Americans withDisabilities Act of 1990, applicants who require accommodation inthe job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunityprotections, please view the ‘EEO is the Law’ poster.

Our environment respects individual differences and recognizeseach employee as an integral member of our company. Our workforcereflects these values and celebrates the individuals who make upour growing team.

Gilead provides a work environment free of harassment andprohibited conduct. We promote and support individual differencesand diversity of thoughts and opinion.

For Current Gilead Employees and Contractors: Gilead Sciences,Inc. is a research-based biopharmaceutical company that discovers,develops and commercialises innovative medicines in areas of unmetmedical need. With each new discovery and investigational drugcandidate, we seek to improve the care of patients living withlife-threatening diseases around the world. Gilead’s therapeuticareas of focus include HIV/AIDS, liver diseases, cancer andinflammation, and serious respiratory and cardiovascularconditions.

If this is not the right move for you now but remain interestedin a career at Gilead Sciences please connect with us via ourtalent community

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Keywords: Gilead Sciences, Inc., Seattle , Sr. Director, Clinical Research (MD) - Inflammation, Other , Seattle, Washington

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Keywords: Gilead Sciences, Inc., Seattle, Seattle , Director, Clinical Research, Other , Lynnwood, Washington

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