Associate Director, Epidemiology

Location
Foster City
Salary
See job description.
Posted
November 18 2020
Ref
R0014486
Position Type
Full Time
Organization Type
Pharma


Associate Director, Epidemiology
United States - California - Foster City

Gilead 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats 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 #CreatingPossible


Associate Director, PVE - Epidemiology

Job Description Summary

The 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 institution

MPH/MS in epidemiology or a related field, with 5+ years of relevant experience

Pharmaceutical industry and/or CRO experience is preferred
Experience 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 recommended

Key Responsibilities:

Independently, or with minimal oversight, design, direct, and execute observational studies, including pharmacoepidemiology studies and non-interventional studies

Oversee and/or actively contribute to the completion of all analytical/validation activities for studies/projects, in collaboration with programmers

Develop and/or review Statistical Analysis Plans

Anticipate obstacles and difficulties that may arise and resolves them in a collaborative manner

Independently represent Epidemiology to individuals outside the organization and serve as a cross-functional resource

Support and/or lead other Epidemiology activities, including interaction with CROs, to accomplish business objectives

Provide epidemiologic input into Pharmacovigilance Plans

Participate in special projects based on extensive knowledge base, experience and competency

Contribute to and lead internal and external educational initiatives

Contribute to and lead interpretation of analysis results and preparation of study reports, conference abstracts and presentations, and manuscripts

Maintain and apply knowledge of epidemiologic principles, analysis methods, and data resources

Contribute to preparation and review of safety documents in response to regulatory authorities

Identify, assess, and integrate/implement new data resources, methods, technology and analytic tools

Actively contribute to identification and assessment of safety signals and trends using active surveillance methods

Oversee and/or actively contribute to analysis/validation projects utilizing industry-standard analytic tools

Comply with all regulatory requirements and maintain confidentiality

Participate in and may lead intra-departmental and inter-departmental cross-functional project teams

Participate in process improvement initiatives, including SOP/WRK updates and audits

Mentor junior departmental staff to ensure competence in epidemiologic skills and knowledge

Knowledge and Skills

Demonstrate excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines

Possess excellent verbal, written communication and interpersonal skills

Demonstrates ability to be solely responsible for all scientific aspects of an observational study

Demonstrates ability to guide the study management team through complex decisions beyond study design

Associate Director, PVE - Epidemiology

Job Description Summary

The 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 institution

MPH/MS in epidemiology or a related field, with 5+ years of relevant experience

Pharmaceutical industry and/or CRO experience is preferred
Experience 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 recommended

Key Responsibilities:

Independently, or with minimal oversight, design, direct, and execute observational studies, including pharmacoepidemiology studies and non-interventional studies

Oversee and/or actively contribute to the completion of all analytical/validation activities for studies/projects, in collaboration with programmers

Develop and/or review Statistical Analysis Plans

Anticipate obstacles and difficulties that may arise and resolves them in a collaborative manner

Independently represent Epidemiology to individuals outside the organization and serve as a cross-functional resource

Support and/or lead other Epidemiology activities, including interaction with CROs, to accomplish business objectives

Provide epidemiologic input into Pharmacovigilance Plans

Participate in special projects based on extensive knowledge base, experience and competency

Contribute to and lead internal and external educational initiatives

Contribute to and lead interpretation of analysis results and preparation of study reports, conference abstracts and presentations, and manuscripts

Maintain and apply knowledge of epidemiologic principles, analysis methods, and data resources

Contribute to preparation and review of safety documents in response to regulatory authorities

Identify, assess, and integrate/implement new data resources, methods, technology and analytic tools

Actively contribute to identification and assessment of safety signals and trends using active surveillance methods

Oversee and/or actively contribute to analysis/validation projects utilizing industry-standard analytic tools

Comply with all regulatory requirements and maintain confidentiality

Participate in and may lead intra-departmental and inter-departmental cross-functional project teams

Participate in process improvement initiatives, including SOP/WRK updates and audits

Mentor junior departmental staff to ensure competence in epidemiologic skills and knowledge

Knowledge and Skills

Demonstrate excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines

Possess excellent verbal, written communication and interpersonal skills

Demonstrates ability to be solely responsible for all scientific aspects of an observational study

Demonstrates ability to guide the study management team through complex decisions beyond study design

#LI-CS2

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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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our 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 Internal Career Site to apply for this job.


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