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Gilead Sciences, Inc. Clinical Trials Manager, Clinical Operations - Oncology in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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.

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.

This position can be located in Foster City, CA, Morris Plains, NJ, Seattle, WA or remotely in the US. Strong preference to be office based.**

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

  • Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development

  • 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 a RN (2 or 3 year certificate) or 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 is preferred

For Colorado Job Applicants: The salary range for this position is:

$115,600.00 - $173,400.00

Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.

Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' (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/ofccp/pdf/pay-transp_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.

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