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Please log onto your Internal Career Site to apply for this job.Job Description
Sr. Director, Medical Affairs Research (Liver Disease, COVID-19)
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).
This important role focuses on real-world data and PRO data collection, generation, interpretation, and dissemination as well as conducting original research to optimize treatment practices 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 diseases as well as COVID-19.
Principle Roles and Responsibilities:
- In collaboration with Global MAR ED/ TA leads, develops Global Medical Affairs Plans for assigned therapeutic areas and outlines strategic approach for generating required evidence and research output necessary to the plan.
- Lead, develop and ensure the execution of the MAR 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, 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 Epidemiology, 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
- Contribute to assessing data gaps as part of the Integrated Evidence Planning process and provide input on clinical and PRO endpoints with Phase II/III/IV clinical trials in partnership with Medical Affairs, Clinical Development and Commercial
- 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 inclusion
Specific 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 or infectious diseases being able to benchmark various real-world data sources and PRO instruments
- Advanced scientific degree (Ph.D., MD, Pharm.D. or equivalent) ideally Epidemiology, Public Health, Outcomes Research, or Biostatistics, with a minimum of 8+ years of experience in the pharmaceutical industry, and 5+ years of observational research
- 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 ePROs
- Excellent project management and organizational skills, including management of multiple priorities and resources
- 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
- 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%)
- Proven track record of executing clearly defined goals and objectives
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