Sr. Clinical Trials Manager, Clinical Operations- Inflammation

Sr. Clinical Trials Manager, Clinical Operations- Inflammation 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 CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products. EXAMPLE RESPONSIBILITIES: In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines Communicates with functional peers regarding project status and issues and ensure project team goals are met Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out. Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report Coordinates data review to support interim/final data analysis Participates in study strategy development. Maintains study timelines. Contributes to development of study budget. Contributes to development of RFPs and participate in selection of CROs/vendors. Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management). Proactively identifies potential study issues/risks and recommends/implements solutions. Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings. May participates in the recruiting and hiring process for CTMs and supports their professional development May mentor other junior team members Coaches members of a work team and ensures adherence to established guidelines Experience and Skills: BS/BA degree in nursing, science or health related field with 6 years of trial management experience - OR - MS/MA degree in nursing, science or health related field with 4 years of trial management experience Preferred Qualifications Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management Highly developed leadership skills to successfully lead a clinical study team Ability to deal with time demands, incomplete information or unexpected events Must display strong analytical and problem solving skills Attention to detail Outstanding organizational skills with the ability to multi-task and prioritize Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities Meets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency. Knowledge & Other Requirements Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Demonstrated analytical and problem-solving skills Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools. Familiar with standard medical / scientific terminology. Ability to communicate in a clear and concise manner. Ability to support a team-oriented, highly-matrixed environment. Ability to execute multiple tasks as assigned. When needed, ability to travel. The salary range for this position is: $154,020.00 - $199,320.00. 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing 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 ApplicantAccommodationsgilead.com 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. jeid-4a90180889bb984ea3384b6d3027dbc0