Clinical Trials Manager

Socket.dev; Parsippany-Troy Hills (NJ); On-site; USD 133,000 - 190,000; Full time

Job summary

Gilead Sciences is seeking a Clinical Trials Manager (CTM) to support the Oncology pipeline, based in Parsippany, NJ or Foster City, CA. The CTM will drive end-to-end operational delivery of Phase II/III oncology trials, supervise CROs/vendors, and coordinate with internal teams to ensure study objectives are met.

Applicants should have Oncology experience and CRO/pharma/biotech background, with 5+ years BS/BA and 3+ years MS/MA in a related field.

Qualifications

• 5+ Years with BS/BA in a relevant scientific discipline.
• 3+ Years with MS/MA in a relevant scientific discipline.
• Prior Oncology experience and prior CRO/Pharma/Biotech experience is required.

Responsibilities

• Coordinating and supervising all aspects of clinical study.
• Assists Clinical Program Manager in the overall 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 and participate in selection of CROs/vendors.
• May manage CROs/vendors or 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 /vendors are in compliance with protocols, 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 reports and appendices,including resolving any data discrepancies.
• Assists in determining the activities to support a project’s priorities within functional area.
• Develop tools and processes that optimize project efficiencies and effectiveness.
• Travel is required.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• 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 to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• May serve as a resource for others within the company for clinical trials management expertise.
• Under general supervision, is able to examine functional issues from an organizational perspective.
• Must have general, functional expertise to support SOP development and implementation.

Skills

Oncology experience

Clinical Trials Management

Cross-functional leadership

Education

BS/BA in a relevant scientific discipline

MS/MA in a relevant scientific discipline

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

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

Job Summary:

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 project’s 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:

Other US Locations: $133,195.00 - $172,370.00.Bay Area: $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*.

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:

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 [e-mail] assistance.

For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.