Gilead Sciences Inc

Clinical Trials Manager- Late Phase Oncology

Gilead Sciences Inc • $133K — $172K *
Parsippany, NJ 07054In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • 5+ years of clinical trials management experience with a BS/BA in a relevant scientific discipline.
  • 3+ years of relevant experience with an MS/MA in a scientific discipline.
  • Prior oncology experience is required.
  • Background in CRO/Pharma/Biotech is necessary.
  • Strong understanding of FDA/EMEA regulations and GCP guidelines.

Responsibilities

  • Coordinate and supervise all aspects of clinical studies.
  • Assist Clinical Program Manager with overall study management.
  • Provide input on study documents such as protocols and investigator brochures.
  • Maintain study timelines and documentation.
  • Contribute to the development of study budgets and RFPs.
  • Manage relationships with CROs, vendors, and functional service providers.
  • Ensure compliance of CROs/vendors with protocols and regulatory standards.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Discretionary annual bonus based on performance.
  • Eligibility for stock-based long-term incentives.
  • Paid time off.
  • Access to various wellness programs and resources.
Full Job Description

This role will be based out of our Foster City, California or Parsippany, NJ location.

JobSummary:

We are seeking a Clinical Trials Manager(CTM)to support theOncologypipeline.The CTMdrives end-to-end operational delivery ofPhase II and IIIoncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight.This role serves as a keycontributor for study execution and study managementbycoordinatingwith theinternal teams and external partners (including CROs and vendors), andensuring alignment across all stakeholders to achieve studyobjectives. The CTM applies strong project management, clinical, and regulatoryexpertiseto proactivelyidentifyrisks, implement solutions, andmaintainsstudytimelines to meet the study deliverablesforthein-house and/or hybrid model clinical trials.

Prior Oncologyexperience and prior CRO/Pharma/Biotech experienceisrequired.

Job Description/Key responsibilities:

  • Coordinatingand supervising all aspects ofclinicalstudy.

  • Assists Clinical Program Manager intheoverall study management.

  • Provide input into study protocols,investigator brochures,case report forms, and informed consents, final study reports, oversee/author study plans, and presentations.

  • Maintains study timelines.including documentation and communications.

  • Contributes to development of study budget.

  • Contributes to development of RFPs andparticipatein selection of CROs/vendors.

  • May manage CROs/vendorsor functional service providers.

  • May serve as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits.

  • Provide oversight of study sites/region and review routine regulatory documents to ensure that CROs /vendorsare in compliance withprotocols, regulatory requirements, SOPs, and monitoring plans.

  • Ensures effectiveness of site budget/contract process.

  • May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.

  • Coordinates review of data listings and preparation of interim/final clinical study reportsand appendices,including resolving any data discrepancies.

  • Assistsindeterminingthe activities to support a projects priorities withinfunctionalarea.

  • Develop tools and processes thatoptimizeprojectefficienciesand effectiveness.

  • Travel isrequired.

  • Excellent teamwork, communication, decision-makingand organizational skills arerequired.

  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.

  • Must be able togenerally understand, interpret, and explain protocol requirements to others.

  • Mustbe able to prioritize multiple tasks.

  • May serve as a resource for others within the company for clinical trials managementexpertise.

  • Under general supervision,isable toexamine functional issues from an organizational perspective.

  • Must havegeneral, functionalexpertiseto support SOP development and implementation.

Basicqualifications:

  • 5+ Years with BS/BAin a relevant scientific discipline.

  • 3+ Years with MS/MAin a relevant scientific discipline.

People Leader Accountabilities:

  • Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach themoncurrent performance and future potential. They ensure employeesare receivingthe feedbackand insight needed to grow,developand realize their purpose.

  • Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.


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:

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.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

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Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

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At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

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Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

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Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

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Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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