Associate Director, Epidemiology

Associate Director, EpidemiologyUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scaleInclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleAssociate Director, PVE - EpidemiologyJob Description SummaryThe Associate Director, Epidemiology will contribute to the design and execution of observational studies. The person will be actively involved in the planning and preparation of protocols, analyses and interpretation of data, study reports, regulatory documents/submissions, conference abstracts and/or presentations, and manuscripts.The successful candidate will also demonstrate knowledge of statistical programming principles, analysis methods and data resources, and their appropriate use.Specific Education & Experience Requirements:PhD in epidemiology or related field, or an MD/PharmD + MPH/MS in epidemiology or a related field, with 3+ years relevant experience in a pharmaceutical company, contract research organization, or academic institutionMPH/MS in epidemiology or a related field, with 5+ years of relevant experiencePharmaceutical industry and/or CRO experience is preferredExperience in conducting observational studies and data analyses using real-world healthcare databases (e.g., non-interventional studies, electronic medical records, administrative healthcare claims, disease registries, national surveys, etc.) is strongly recommendedKey Responsibilities:Independently, or with minimal oversight, design, direct, and execute observational studies, including pharmacoepidemiology studies and non-interventional studiesOversee and/or actively contribute to the completion of all analytical/validation activities for studies/projects, in collaboration with programmersDevelop and/or review Statistical Analysis PlansAnticipate obstacles and difficulties that may arise and resolves them in a collaborative mannerIndependently represent Epidemiology to individuals outside the organization and serve as a cross-functional resourceSupport and/or lead other Epidemiology activities, including interaction with CROs, to accomplish business objectivesProvide epidemiologic input into Pharmacovigilance PlansParticipate in special projects based on extensive knowledge base, experience and competencyContribute to and lead internal and external educational initiativesContribute to and lead interpretation of analysis results and preparation of study reports, conference abstracts and presentations, and manuscriptsMaintain and apply knowledge of epidemiologic principles, analysis methods, and data resourcesContribute to preparation and review of safety documents in response to regulatory authoritiesIdentify, assess, and integrate/implement new data resources, methods, technology and analytic toolsActively contribute to identification and assessment of safety signals and trends using active surveillance methodsOversee and/or actively contribute to analysis/validation projects utilizing industry-standard analytic toolsComply with all regulatory requirements and maintain confidentialityParticipate in and may lead intra-departmental and inter-departmental cross-functional project teamsParticipate in process improvement initiatives, including SOP/WRK updates and auditsMentor junior departmental staff to ensure competence in epidemiologic skills and knowledgeKnowledge and SkillsDemonstrate excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlinesPossess excellent verbal, written communication and interpersonal skillsDemonstrates ability to be solely responsible for all scientific aspects of an observational studyDemonstrates ability to guide the study management team through complex decisions beyond study designAssociate Director, PVE - EpidemiologyJob Description SummaryThe Associate Director, Epidemiology will contribute to the design and execution of observational studies. The person will be actively involved in the planning and preparation of protocols, analyses and interpretation of data, study reports, regulatory documents/submissions, conference abstracts and/or presentations, and manuscripts.The successful candidate will also demonstrate knowledge of statistical programming principles, analysis methods and data resources, and their appropriate use.Specific Education & Experience Requirements:PhD in epidemiology or related field, or an MD/PharmD + MPH/MS in epidemiology or a related field, with 3+ years relevant experience in a pharmaceutical company, contract research organization, or academic institutionMPH/MS in epidemiology or a related field, with 5+ years of relevant experiencePharmaceutical industry and/or CRO experience is preferredExperience in conducting observational studies and data analyses using real-world healthcare databases (e.g., non-interventional studies, electronic medical records, administrative healthcare claims, disease registries, national surveys, etc.) is strongly recommendedKey Responsibilities:Independently, or with minimal oversight, design, direct, and execute observational studies, including pharmacoepidemiology studies and non-interventional studiesOversee and/or actively contribute to the completion of all analytical/validation activities for studies/projects, in collaboration with programmersDevelop and/or review Statistical Analysis PlansAnticipate obstacles and difficulties that may arise and resolves them in a collaborative mannerIndependently represent Epidemiology to individuals outside the organization and serve as a cross-functional resourceSupport and/or lead other Epidemiology activities, including interaction with CROs, to accomplish business objectivesProvide epidemiologic input into Pharmacovigilance PlansParticipate in special projects based on extensive knowledge base, experience and competencyContribute to and lead internal and external educational initiativesContribute to and lead interpretation of analysis results and preparation of study reports, conference abstracts and presentations, and manuscriptsMaintain and apply knowledge of epidemiologic principles, analysis methods, and data resourcesContribute to preparation and review of safety documents in response to regulatory authoritiesIdentify, assess, and integrate/implement new data resources, methods, technology and analytic toolsActively contribute to identification and assessment of safety signals and trends using active surveillance methodsOversee and/or actively contribute to analysis/validation projects utilizing industry-standard analytic toolsComply with all regulatory requirements and maintain confidentialityParticipate in and may lead intra-departmental and inter-departmental cross-functional project teamsParticipate in process improvement initiatives, including SOP/WRK updates and auditsMentor junior departmental staff to ensure competence in epidemiologic skills and knowledgeKnowledge and SkillsDemonstrate excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlinesPossess excellent verbal, written communication and interpersonal skillsDemonstrates ability to be solely responsible for all scientific aspects of an observational studyDemonstrates ability to guide the study management team through complex decisions beyond study design#LI-CS2For 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 be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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 mailto:careers@gilead.comfor assistance.For more information about equal employment opportunity protections, please view the http://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf poster.http://www.dol.gov/whd/regs/compliance/posters/eppac.pdfhttp://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdfhttps://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdfOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld to apply for this job.To apply, visit https://apptrkr.com/2026065Copyright ©2017 Jobelephant.com Inc. All rights reserved.https://www.jobelephant.com/jeid-dc78cf62af4cf14dbd1ad409a4d69a58