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Associate Director, Epidemiology

Gilead Sciences

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Location: Foster City, CA Posted Date: 4/26/2013 Position Type: Full time Job Code: 12447 Required Education: High school or equivalent Areas of Expertise Desired: Drug Safety
Epidemiology

Description

Due to our continued growth, Gilead Sciences is seeking an Associate Director, Epidemiology. This position is based in Foster City, CA. Relocation assistance is available.

Gilead was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies.



Associate Director, Epidemiology


The Associate Director, Epidemiology will design and analyze epidemiology studies.

Specific Responsibilities and skills for Position:

The Associate Director, Epidemiology implements and maintains the business of Gilead Epidemiology and provides epidemiological input into processes and policies related to the analysis and use of epidemiological data.

* Contributes in the establishment and development of an epidemiology group that will provide epidemiology advice and services to the organization, as needed.
* Maintains a thorough knowledge of epidemiologic principles, analysis methods and data resources as well as indications for their appropriate use.
* Provides an in-depth understanding and will advise in the design of observational study.
* Provides project leadership for the development and implementation of epidemiology methods and technology used in the assessment of risk.
* Provides expert level consultation epidemiological questions to a variety of stake holders across the company and assists with observational study and registry design.
* Establishes and manages a team of professionals skilled in epidemiology methods and technical procedures necessary to present and maintain concise data for analysis.

Essential Duties and Job Functions:

* Provides epidemiologic input into the design of company Risk Management Plans and or REMS.
* Leads the design of observational studies (prospective and retrospective), including registries.
* Provides advice in the design of epidemiologic studies using claims databases or electronic medical records.
* Actively participates in the analysis of epidemiologic studies using SAS and/or STATA.
* Complies with all regulatory requirements from competent authorities; maintains confidentiality; meets all safety reporting deadlines
* Collaborates with drug safety’s pharmacovigilance scientists in the identification and assessment of safety signals and trends from epidemiological studies.
* Works under consultative direction toward long-range goals and objectives, taking into account and providing support for the strategic goals of the organization; translates overall direction and strategy, communicates across organizational levels and functions; interprets and executes policies and procedures, and provides direction based on general policies and management guidance
* Participates in process improvement initiatives, identifies areas for improvement, and presents solutions
* Participates in intradepartmental and interdepartmental cross-functional project teams; communicates across organizational levels and functions
* Participates in both internal and external educational initiatives; mentors junior staff to ensure competence in pharmacovigilance skills and knowledge
* Participates in literature review process on an ad hoc basis
* Participates in SOP updates, audits, data analysis, and other ad hoc activities
* Contributes to preparation and review of safety documents in response to regulatory inquiries
* Demonstrates strong proficiency in verbal and written communication
* Demonstrates excellent attention to detail, teamwork and initiative, with flexibility and ability to adapt to the needs of the organization; maintains meticulous attention to project deadlines.
* May recruit, hire, mentor, and manage direct reports, with responsibility for employee performance evaluations
* May participate in budget planning and management.

Requirements

* Typically requires a MD with a master in Epidemiology or a PhD in Epidemiology with demonstrated ability to handle the responsibilities, deliverables, and skills required for this level.
* Significant experience (7+ years) of epidemiological study work including 3 years of industry experience). Prior clinical research is preferred.
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