Sr. Medical Affairs Associate
Sr. Medical Affairs Associate
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
Medical Affairs plays a key role in developing Integrated Evidence Plans (IEPs) that include a holistic view of evidence gaps and prioritized data needs across the product lifecycle. Data generation needs extend from phase 2, though phase 3, launch, and post launch activities and should consider how MA will generate and use research data including disease burden, unmet medical need, patient reported outcomes (PRO), Real World Data/Evidence (RWD/RWE) and observational studies, as well as Investigator Sponsored Research (ISR) and Collaborative studies. Medical Affairs Research (MAR) convenes cross-functional working groups to develop drug specific Integrated Evidence Plans (IEPs) as a roadmap to quality data generation, to inform treatment practice and to improve patient outcomes.
We are seeking a well-organized research professional to join the MAR team, reporting to the head of Integrated Evidence Planning. The role will support the development, implementation, and management of IEP generation, as well as Real World Data/Evidence (RWD/RWE) working groups across all Gilead therapeutic areas (TAs). In addition, the role will include management and leadership of one or more Medical Affairs research studies. The Therapeutic Area (TA) portfolio is particularly stimulating and broad based and ranges from established products for diseases such as HIV, Hepatitis B and C, to newer therapeutic areas, such as oncology and COVID-19.
Responsibilities of this role will include:
- Work with cross functional partners in Value and Access/ HEOR, Clinical Development, epidemiology, and others on IEP process focusing on data generation needs for each TA
- Assist with refinement and standardization of IEP processes
- Provide insights into selection of study types for each identified data gap (i.e., post hoc analysis of registrational data, new phase 3b/4 study, ISR or Collaborative Study, prospective observational study, patient reported outcomes (PRO), registry, claims or EMR data analysis (RWD) or meta-analysis)
- Ensure that the IEP process and execution aligns with the overall medical strategy and activities to demonstrate the value of Gilead products
- Ensure alignment of MA IEP with data generation activities from other functional areas including Value and Access, HEOR, epidemiology and Clinical Development
- Organize cross-functional working group meetings charged with developing and managing the IEP, data generation and RWD activities
- Manage/lead research studies within MAR
- Enthusiastically collaborate with a diverse group of colleagues in different geographies and across several groups within and outside Medical Affairs
- 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
Knowledge, Experience and Skills:
Requires a MS/MPH, PhD, or PharmD in epidemiology, biostatistics, HEOR, public health, pharmacy, or related fields. 2+ years of strong research experience, as well as excellent verbal and written communication, interpersonal, organizational, and problem-solving skills are required. The ability to work on several projects with tight timelines while maintaining excellent attention to detail is also key to success in this role.
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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 email@example.com for assistance.
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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