GILEAD
Clinical Operations Manager
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 fulfill their aspirations. Join Gilead and help create possible, together. 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. Key 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 participates in selection of CROs/vendors. Provides 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 participate 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. Basic Qualifications
BS/BA degree in nursing, science, or health-related field with at least 5 years of trial management experience - OR - MS/MA degree in nursing, science, or health-related field with at least 3 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 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: $146,540.00 - $189,640.00. 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. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, 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 ApplicantAccommodations@gilead.com for assistance. 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.
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 fulfill their aspirations. Join Gilead and help create possible, together. 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. Key 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 participates in selection of CROs/vendors. Provides 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 participate 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. Basic Qualifications
BS/BA degree in nursing, science, or health-related field with at least 5 years of trial management experience - OR - MS/MA degree in nursing, science, or health-related field with at least 3 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 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: $146,540.00 - $189,640.00. 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. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, 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 ApplicantAccommodations@gilead.com for assistance. 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.