Clinical Trial Manager - Oncology

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 146,000 - 190,000; Full time

Job summary

An established industry player in biopharmaceuticals is seeking a Clinical Trial Manager to join their Oncology team. This role involves managing clinical trials from inception to completion, ensuring compliance with regulatory standards while working collaboratively with diverse teams. The ideal candidate will have a strong background in clinical operations, particularly in oncology, and possess excellent communication and organizational skills. Join a company dedicated to innovation and improving lives through cutting-edge therapies. This is an exciting opportunity to make a significant impact in the field of medicine.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Company-sponsored medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• 5+ years of experience in clinical trials management.
• Thorough knowledge of FDA/EMA regulations and ICH guidelines.
• Experience in oncology clinical trials preferred.

Responsibilities

• Drafts and coordinates clinical trial documents and reports.
• Maintains study timelines and coordinates data review.
• Participates in recruiting and hiring for clinical trial roles.

Skills

Teamwork

Communication

Decision-making

Organizational skills

FDA Regulations knowledge

EMA Regulations knowledge

GCP knowledge

Oncology clinical trials experience

Education

BS/BA in a relevant scientific discipline

Masters' degree or higher in a scientific discipline

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Clinical Trial Manager - Oncology page is loaded

Clinical Trial Manager - Oncology

Apply locations United States - California - Foster City United States - New Jersey - Parsippany time type Full time posted on Posted Yesterday job requisition id R0045224

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.

**This position can be located in Foster City, CA or Parsippany, NJ. This is NOT a remote position***

RESPONSIBILITIES:

• 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

SKILLS:

• At least 5+ years of experience and BS/BA in a relevant scientific discipline OR

• 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: $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] for assistance.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 apply via the Internal Career Opportunities portal in Workday.

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About Us

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.