Clinical Trials Manager, Early Phase Oncology

Regulatory Jobs; Foster City (CA); Vor Ort; USD 147.000 - 190.000; Vollzeit

Zusammenfassung

Gilead Sciences Inc. in Foster City, CA (or Parsippany, NJ) is seeking a Clinical Trials Manager to lead end-to-end delivery of early-phase oncology trials in a hybrid/office-based setting.

The CTM will coordinate with internal teams and CROs, maintain study timelines, and ensure quality execution while managing budgets and vendor relationships. Prior CRO/pharma and oncology experience are required.

Qualifikationen

• Bachelor's degree with 5+ years of relevant scientific experience or Master's with 3+ years.
• Experience in CRO/pharma and oncology is required/preferred.
• Strong project management and cross-functional leadership skills.

Aufgaben

• Coordinate and supervise all aspects of the clinical study.
• Assist Clinical Program Manager in overall study management.
• Draft and coordinate review of protocols, informed consent, CRFs, monitoring plans and reports.
• Maintain study timelines and contribute to budget development.
• Contribute to CRO/vendor selection and management.
• Review data listings and prepare interim/final study reports.
• Contribute to abstracts, presentations, and manuscripts; ensure budget/contract processes.
• Train CROs, vendors, investigators, and study coordinators on study requirements.
• Prioritize activities to support project priorities.
• Under supervision, design scientific communications within the company.
• Travel is required.
• Exhibit excellent teamwork, communication, and organizational skills.
• Knowledge of FDA/EMEA Regulations, ICH Guidelines, and GCPs is desirable.
• Explain protocol requirements to others and prioritize multiple tasks.
• Serve as a resource for clinical trials management.
• Under supervision, examine issues from an organizational perspective.
• Support SOP development and implementation.

Kenntnisse

Cross-functional leadership

Project management

CRO/vendor oversight

Regulatory knowledge (FDA/EMEA/ICH/GCP

Communication skills

Ausbildung

Bachelor's degree in a relevant scientific discipline

Master's degree in a relevant scientific discipline

Jobbeschreibung

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

We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The CTM drives end-to-end operational delivery of early-phase oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with the internal teams and external partners (including CROs and vendors), and ensuring alignment across all stakeholders to achieve study objectives. The CTM applies strong project management, clinical, and regulatory expertise to proactively identify risks, implement solutions, and maintains study timelines to meet the study deliverables for the in-house and/or hybrid model clinical trials.

This is one of three office-based positions located in Foster City, CA or Parsippany, NJ

**Prior CRO/Pharma experience REQUIRED.

**Prior Oncology experience REQUIRED.

**Early Development/Early Phase Oncology experience preferred but not REQUIRED.

Key Responsibilities:

• Coordinating and supervising all aspects of clinical study.

• Assists Clinical Program Manager in the overall study management.

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.

• Maintains study timelines.

• Contributes to development of study budget.

• Contributes to development of RFPs and participate in selection of CROs/vendors.
  Manage CROs/vendors.

• Coordinates review of data listings and preparation of interim/final clinical study reports.

• May contribute to development of abstracts, presentations, and manuscripts,
  Ensures effectiveness of site budget/contract process.

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

• Assists in determining the activities to support a project’s priorities within functional area.

• Under supervision, they may design scientific communications within the company.

• 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.

Basic Qualifications:

• Bachelor's Degree and Five Years’ Experience in a relevant scientific discipline. OR

• Masters' Degree and Three Years’ Experience in a relevant scientific discipline.

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.

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.