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Manager, Global Medical Affairs, Phase 4 Research
4 months ago
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. 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 scale
Inclusion 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 #CreatingPossible
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
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. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia and Australia. For more information please visit
Manager, Global Medical Affairs Phase 4 (LIFE)
We are seeking a talented manager for our Phase IV Research in LIFE (liver, inflammation, fibrosis, and established products) to join our team. This role will support all LIFE therapeutic areas but will have a primary focus in Primary Biliary Cholangitis (PBC). The ideal candidate will have previous experience in clinical operations or phase 4 research.
Job Responsibilities
Support data generation activities through:
Critical review of global investigator-sponsored research (ISR) and collaborative Phase IV study proposals
Managing the LIFE Phase IV portfolio including liaising with key cross-functional partners such as clinical operations and local affiliates
Reviewing abstracts and/or manuscripts that result from the phase IV program
Create and manage LIFE requests for proposals (RFPs)
Collaborate with other GMA teams and team members, affiliate country liver disease teams, and other cross functional partners to contribute to development of the Integrated Evidence Plan (IEP) and Data Generation plans
Serve as member and key contributor to the Execution Team in Primary Biliary Cholangitis, to drive Medical Affairs research contributions to data generation
Create study metric trackers
Prepare presentation materials related to the LIFE Phase IV Program
Socialize Phase IV outputs to cross-functional partners
Support external investigators, medical science liaisons, and other stakeholders in developing and submitting rigorous research proposals to Gilead
Project management related to LIFE Phase IV Research
Other activities, as assigned, to support the Global Medical Affairs LIFE team
Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and providing updates to relevant partners.
Attend scientific conferences and helps coordinate medical affairs activities at conferences and may present to external audience.
Other activities, as assigned, to support GMA Primary Biliary Cholangitis and Virology.
Essential Skills
Excellent written, verbal and interpersonal communication
Excellent organizational skills to support project planning across multiple activities; ability to anticipate and prioritize workload
Organized; attention to detail and able to meet timelines in a fast-paced environment
Must be fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials
Must be able to work autonomously and independently
Ability to work in a global environment which will require participation in meetings outside of standard work hours to accommodate time zone differences
Requirements:
Ideal candidate will have an advanced medical/scientific degree (e.g., MD, PhD, Pharm D, NP/PA). Bachelor's degree and 6 years' experience, or advanced degree and 4 years' experience
Experience in at least one of the therapeutic areas that the Liver Disease team is currently engaged in (HBV/HCV/HDV/PBC) is highly desired.
Industry experience in Medical Affairs, Clinical Development, or Research or success in a similar role outside of the biotech/pharmaceutical industry is highly desired.
Ability to think strategically and translate that strategy into an actionable work plan.
Excellent communication skills, including written, verbal, interpersonal, relationship-building and negotiations.
Excellent organizational skills to support project planning and execution across multiple activities; anticipate and prioritize workload.
Excellent teamwork skills. Organized; attention to detail and able to meet timelines in a fast-paced environment.
Excellent analytical and problem-solving skills; demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications.
Experience in developing effective abstracts, manuscripts, posters and slides and preparing presentations at scientific meetings.
Must be fully aware and compliant with regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
Able to work with a high level of autonomy and independence.
Gilead Core Values
Integrity (Doing What's Right)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Inclusion (Encouraging Diversity)
The salary range for this position is: $143, $185, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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