Assoc Director, Clinical Data Management
Assoc Director, Clinical Data Management
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 CLINICAL DATA MANAGEMENT
- Leads and provides oversight for the execution of data management activities for more than one compound in a therapeutic area and may have accountability for CDM activities across a therapeutic area.
- Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for complex clinical data acquisition, quality checking and reporting.
- Ensure completeness, accuracy and consistency of clinical data and data structure across all projects.
- Responsible for putting together highly effective CDM teams and delivering a clear sense of direction.
- Anticipates complex obstacles and difficulties of clients and acts upon them in order to meet team goals
- Solves complex problems by appropriately managing or escalating issues to senior management
- Demonstrates a proven ability to address Regulatory Submission issues within Clinical Data Science and with other related departments.
- Examines complex CDM technical issues from various perspectives by utilizing appropriate CDM concepts and resources.
- Leads complex initiatives to gather, organize, and analyze interim clinical data from various data sources, such as Virology.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Highly knowledgeable in FDA/EMA regulations and has an in-depth familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA.
- Leads data management activities for regulatory submissions with minimal supervision.
- Provides input into CDM organizational strategy and implements departmental change.
- May have accountability for delivery of departmental infrastructure projects.
- Leads the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
- Leads the compilation of responses to questions and findings from Clinical Quality Assurance (CQA) and other audits at the study / vendor level.
- Anticipates internal resource needs and external costs for the short and long term. Works with director level management and HR to ensure long-term resource allocation within a therapeutic area.
- Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner
Education & Experience
- 10 years of experience and a BS degree.
- 8 years of experience and a MS degree.
- 2 years of experience and a PhD degree
- Experience leading DM activities for oncology trials (solid tumor and hematology)
- Experience managing/overseeing several oncology trials simultaneously
- Experience managing DM activities for dose escalation/expansion and phase 3 oncology trials
- Familiar with response assessment criteria (e.g. RECIST, Cheson, Hallek)
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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 firstname.lastname@example.org opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2507537&targetURL=mailto:email@example.com">firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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