Senior Director, Medical Affairs Observational Research

Foster City, CA, US
Oct 20, 2020
Required Education
Position Type
Full time
Senior Director, Medical Affairs Observational ResearchUnited 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 #CreatingPossibleSenior Director, Medical Affairs Observational Research- Liver Disease, Fibrosis and COVID-19 (LFC)Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia and Australia. Gilead's therapeutic areas of focus include HIV/AIDS, COVID-19, liver diseases, fibrosis, cancer and inflammation.The role of Real World Data (RWD) has greatly expanded and has been recognized to providing value to determine comparative effectiveness, longer-term safety and efficacy outcomes, rationale for payor and clinical decisions and an evolving role in the regulatory process. Gilead's commitment to research emphasizes the importance of continued focus on science and patient outcomes throughout the lifecycle of our compounds. As such, Medical Affairs maintains a robust research portfolio across our therapeutic areas including investigator initiated studies, collaborative studies, Medical Affairs led prospective research and studies encompassing RWD and patient reported outcomes (PRO). Medical Affairs Observational Research (MAOR) focuses on real-world data and PRO data collection, generation, interpretation and dissemination and conducts original research to optimize treatment practice and improve patient outcomes throughout the lifecycle of our medicines.We have the following exciting opportunity in our Foster City, CA location. We are seeking an experienced, well organized professional who will develop, implement and manage RWD and Observational Research (OR) strategies and tactics to demonstrate the value of pipeline and inline products in Liver disease, Fibrosis and COVID-19 (LFC). The LFC portfolio is particularly stimulating and broad based and includes research planning and implementation in established (Hepatitis B and C) as well as newer therapeutic areas- COVID-19 (planning for data generation for new therapies) and NASH (late phase development).Principle Roles and Responsibilities:• In collaboration with Global MAOR ED/ TA leads, develops Global Medical Affairs Plans for Liver Disease, fibrosis and COVID-19 and outlines strategic approach for generating required evidence and research output necessary to the plan.• Lead, develop and ensure the execution of the MAOR medical strategy and activities to demonstrate the value of Gilead products• Research activities will focus on the broad areas of pharmacoepidemiology and will include retrospective database analyses, prospective cohort studies, and patient reported outcomes (PRO) and real world research• Create study concept documents, protocols, analysis plans, and final study reports, as well as draft manuscripts for studies which include OR/PRO components• Work cross functionally to assess, evaluate and select which data sources, cohorts, registries and collaborators represent the best partners to achieve the strategic objectives and data generation plans• Collaborate with colleagues in multiple other functional areas, including HEOR, Therapeutic Area Medical Directors, Commercial Strategy and Clinical Development• Provide high quality OR technical and methodological support to cross-functional teams to effectively use clinical, and humanistic data to optimize treatment practice and improve patient outcomes throughout the lifecycle of our medicines• Collaborate with MA, Clinical Development, and Commercial to assess data gap and to provide input on OR (clinical, patient-reported outcomes) endpoints with Phase II/III/IV clinical trials• Develop OR communications (e.g., manuscripts, scientific forum presentations, slide decks) to build the peer reviewed published scientific evidence base• Maintain and continue to enhance knowledge of technical and methodological advances and trends to ensure best approaches are used in OR studies and evaluations• Engage key clinical and OR experts and facilitate the building of relationships via collaboration on various projects. Provide OR support at advisory boards, regional educational programs, conferences and other external meetings• Adhere to all applicable pharmaceutical codes, Office of Inspector General (OIG) guidelines, and Gilead policies• Exhibit Gilead's core values: integrity, teamwork, accountability, excellence, and inclusionSpecific Education, Skills and Experience Requirements:• Deep knowledge and prior working experience in fields of Gilead's areas of interest, especially RWD and PRO in Liver Disease (Hepatitis B and C), NASH and COIVD-19, being able to benchmark various real-world data sources and PRO instruments• Advanced scientific degree (Ph.D., MD, Pharm.D. or equivalent) ideally in Epidemiology or Biostatistics, with a minimum of 8+ years of experience in the pharmaceutical industry, and 5+ years of observational research• Will consider relevant academic experience in a high quality academic institution• Strong methodological knowledge including retrospective and prospective study design and analysis, database assessment (including quality assurance metrics to ensure validity and robustness of the data elements) and analysis, advanced statistical methods needed for observational data, real world studies and/ or PRO development• Understanding and work with causal inference methods for RWD• Development and analysis of PRO instruments including digital capture of PRO and use of wearable devices strongly preferred• Excellent project management and organizational skills, including management of multiple priorities and resources• Proven track record of executing clearly defined goals and objectives• Affinity for a collaborative, team-oriented environment and approach; ability to network and partner with internal and external stakeholders, including medical thought-leaders, and academic institutions• Independent research experience either in industry or academia with a proven ability to design, conduct and analyze clinical research data especially real world (clinical cohort) data; publication record will be important• Ability to prepare OR abstracts for conferences and experience drafting, reviewing, and editing manuscripts• A comprehensive understanding of global healthcare systems and stakeholders• Excellent oral and written communication skills and interpersonal skills• Knowledge of Microsoft Office suite (Word, PowerPoint, Excel, Access, and Outlook) is required• Ability to travel frequently (+/- 30%)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 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 poster. 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!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld to apply for this job.To apply, visit ©2017 Inc. All rights reserved.