SENIOR MANAGER, GLOBAL MEDICAL AFFAIRS (HDV)

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 DescriptionGilead 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, and Australia.  We have the following exciting opportunity to be based in our Foster City location.Job DescriptionSenior Manager, Global Medical Affairs (Hepatitis D)This is a position within the Medical Affairs organization that reports to the Director of Global Medical Affairs, HDV. This is a global role supporting the overall HDV strategy development, execution and data generation in late phase from review/approval process, managing ongoing studies, handling ad hoc issues and tracking final publication as outcome.The individual must be a self-starter and able to learn and adapt to evolving system and policies,The key functions of this role will be to collaborate with multiple internal and external stakeholders including the Foster City Medical Affairs team, Medical Affairs Research, Scientific communications, country affiliate Medical Affairs, Clinical operations, Finance and Legal on both the global and regional levels.Specific Job RequirementsManage and oversee projects such deck creation/update, encore strategy, late phase program as to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative mannerSupports conference planning for major conferences, Plan of action development and execution, IEP refresh, potential launched across the globe and county insights gathering.Works collaboratively with Gilead personnel in Global Medical Affairs, across Medical Affairs, Clinical Research, Marketing, Market Access, HEOR, Global Safety and Medical CommunicationCollaborate with project management, medical communications and commercial teams in multiple areas including publication planning, speaker education programs, regional consultant meetings, manuscript review and conference preparationWorking on early development of a variety of projects, he/ she will provide independent thought and initiative in the further development of specific projects and ensuing presentations and reportsUndertakes material review, oversee successful encore process,Supports the successful delivery of the Medical Plan of ActionResponds to clinical and scientific inquiries regarding marketed or developmental Gilead productsAttends major conferences and help coordinate medical affairs activities at conferences and may present to external audienceNational/International travel as requiredProject management regarding Late phase programs.IRC/GRC planning by making sure the fit-for-purpose reviewers are well informed and invited for the meeting under guidance.Maintain a centralized HDV late phase tracker and ensure latest update strategic discussions.Ensure progress of newly approved studies as well as ongoing studies to be completed at a timely manner.Demonstrate ability to rapidly establish a credible knowledge base for company policy, SOPs and high level TA specific knowledge in order to effectively align on the TA’s needs on data generation activities. TAs including but not limited to Hepatitis B, Hepatitis C, Hepatitis D, Inflammation, fibrosis and fungal infectionsPrepare presentation materials for internal, external use.Essential Skills:Excellent written, verbal and interpersonal, relationship-building, and level negotiating communication skillsExcellent organizational skills to support project planning across multiple activities, anticipate and prioritize workloadExcellent teamwork skills. Organized; attention to detail and ability to meet timelines in a fast-paced environmentExcellent 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 publicationsExperience in developing effective abstracts, manuscripts, posters, and slides and presenting at scientific meetingsMust be fully cognizant and adhere to 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 trialsMust be able to work with autonomy and independenceAbility to work in a global environment which will require participation in meetings outside of standard work hours and on the weekends to accommodate time zone differencesKnowledge, Experience & Skills8 + years of relevant experience with Bachelor’s degree in a scientific field is required or 6 years with an advanced degree or 0-2 years with a PhDPreferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring, and scientific expertiseOrganizational skills to manage multiple projects simultaneously.Knowledge of pharmaceutical industry, business conduct and legal/health system environmentGilead Core ValuesIntegrity (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: $165,580.00 - $214,280.00. 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.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 [email protected] for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.SummaryLocation: United States - California - Foster CityType: Full time