Clinical Trial Manager, Clinical Operations- Virology

Clinical Trial Manager, Clinical Operations- Virology (Early Phase) Clinical Trial Manager, Clinical Operations- Virology (Early Phase) United States - New Jersey - Parsippany, United States - California - Foster City Clinical Development & Clinical Operations Regular Job Description 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 is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will manage assigned clinical studies or multiple components of larger studies. You will manage Phase I Virology studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives. EXAMPLE RESPONSIBILITIES: The Early Phase group works only in Phase 1, in healthy volunteers. Phase I is very fast paced with startup to CSR within short timelines. You need experience understanding the protocol and CSR writing processes. This role will oversee multiple studies- approximately two to four studies. Most of the studies are run in the US but may also be conducted globally. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. • MA / MS / PharmD / PhD with 3+ years’ relevant clinical or related experience in life sciences. • BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences. • Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams. • Experience managing the work of external vendors. 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. • Ability to manage any component of full cycle study management, from start-up to close-out. • Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness. • Familiar with standard medical / scientific terminology. • Ability to communicate in a clear and concise manner. • Ability to support a team-oriented, highly-matrixed environment and the ability to execute multiple tasks as assigned. • Phase 1 experience is a plus but not mandatory The salary range for this position is: Bay Area: $146,540.00 - $189,640.00.Other US Locations: $133,195.00 - $172,370.00.Job Description 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 is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will manage assigned clinical studies or multiple components of larger studies. You will manage Phase I Virology studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives. EXAMPLE RESPONSIBILITIES: The Early Phase group works only in Phase 1, in healthy volunteers. Phase I is very fast paced with startup to CSR within short timelines. You need experience understanding the protocol and CSR writing processes. This role will oversee multiple studies- approximately two to four studies. Most of the studies are run in the US but may also be conducted globally. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Minimum Education & Experience • MA / MS / PharmD / PhD with 3+ years’ relevant clinical or related experience in life sciences. • BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences. • Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams. • Experience managing the work of external vendors. 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. • Ability to manage any component of full cycle study management, from start-up to close-out. • Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness. • Familiar with standard medical / scientific terminology. • Ability to communicate in a clear and concise manner. • Ability to support a team-oriented, highly-matrixed environment and the ability to execute multiple tasks as assigned. • Phase 1 experience is a plus but not mandatory The salary range for this position is: Bay Area: $146,540.00 - $189,640.00.Other US Locations: $133,195.00 - $172,370.00.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: 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 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 ACTYOUR 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 apply via the Internal Career Opportunities portal in Workday. Share: Job Requisition ID R Full Time/Part Time Full-Time Job Level Associate Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr