Gilead Sciences
Clinical Trials Manager, Clinical Operations- Oncology
Gilead Sciences, San Mateo, California, United States, 94409
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) 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 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.
Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead’s operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.
Clinical Trials Manager, Clinical Operations - Oncology (CTM)
We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team.
Specific Responsibilities and Skills for Position:
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
Must be able to understand, interpret and explain protocol requirements to others
Maintains study timelines
Coordinates review of data listings and preparation of interim/final clinical study reports
Assists in determining the activities to support a project’s priorities within functional area
Contributes to development of RFPs and participates in selection of CROs/vendors
May be asked to train CROs, vendors, investigators and study coordinators on study requirements
Contributes to development of study budget
May serve as a resource for others within the company for clinical trials management expertise
Able to examine functional issues from an organizational perspective
May contribute to development of abstracts, presentations and manuscripts
Under supervision, may design scientific communications within the company
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Must have a general, functional expertise to support SOP development and implementation
Travel may be required
Knowledge:
Excellent teamwork, communication, decision-making and organizational skills are required
Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
Working knowledge and experience with Word, PowerPoint and Excel
Experience and Skills:
At least 5+ years of experience and BS/BA in a relevant scientific discipline
At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
Prior oncology clinical trials experience
The salary range for this position is: $130,220.00 - $168,520.00. 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) 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 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.
Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead’s operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.
Clinical Trials Manager, Clinical Operations - Oncology (CTM)
We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team.
Specific Responsibilities and Skills for Position:
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
Must be able to understand, interpret and explain protocol requirements to others
Maintains study timelines
Coordinates review of data listings and preparation of interim/final clinical study reports
Assists in determining the activities to support a project’s priorities within functional area
Contributes to development of RFPs and participates in selection of CROs/vendors
May be asked to train CROs, vendors, investigators and study coordinators on study requirements
Contributes to development of study budget
May serve as a resource for others within the company for clinical trials management expertise
Able to examine functional issues from an organizational perspective
May contribute to development of abstracts, presentations and manuscripts
Under supervision, may design scientific communications within the company
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Must have a general, functional expertise to support SOP development and implementation
Travel may be required
Knowledge:
Excellent teamwork, communication, decision-making and organizational skills are required
Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
Working knowledge and experience with Word, PowerPoint and Excel
Experience and Skills:
At least 5+ years of experience and BS/BA in a relevant scientific discipline
At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
Prior oncology clinical trials experience
The salary range for this position is: $130,220.00 - $168,520.00. 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.