Clinical Trials Manager, Clinical Operations (Oncology)

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

Job summary

Join a mission-driven biopharmaceutical organization that values diversity and inclusion. As a Clinical Trials Manager in Oncology, you will play a crucial role in executing Phase 1-4 clinical trials, ensuring compliance with regulatory guidelines, and delivering high-quality clinical data. Your expertise in oncology clinical trials and strong communication skills will help advance the care of patients suffering from life-threatening diseases. This is an exciting opportunity to make a significant impact in a dynamic environment where your contributions will be valued and recognized. If you're ready to change the world and improve lives, this role is for you.

Benefits

Discretionary Annual Bonus

Stock-Based Long-Term Incentives

Paid Time Off

Company-Sponsored Medical Insurance

Company-Sponsored Dental Insurance

Company-Sponsored Vision Insurance

Life Insurance Plans

Qualifications

• 5+ years of experience in clinical trials management or 3+ years with a Master's degree.
• Thorough knowledge of FDA/EMA regulations and GCP.

Responsibilities

• Draft and coordinate clinical trial documents and maintain study timelines.
• Train CROs and vendors on study requirements and contribute to budget development.

Skills

Teamwork

Communication Skills

Decision-Making

Organizational Skills

Oncology Clinical Trials Experience

FDA Regulations Knowledge

GCP Compliance

Education

BS/BA in a Relevant Scientific Discipline

Masters' Degree or Higher

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Clinical Trials Manager, Clinical Operations (Oncology)
United States - California - Foster City
United States - New Jersey - Parsippany

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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.

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:

1. Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
2. Must be able to understand, interpret and explain protocol requirements to others.
3. Maintains study timelines.
4. Coordinates review of data listings and preparation of interim/final clinical study reports.
5. Assists in determining the activities to support a project's priorities within functional area.
6. Contributes to development of RFPs and participates in selection of CROs/vendors.
7. May be asked to train CROs, vendors, investigators and study coordinators on study requirements.
8. Contributes to development of study budget.
9. May serve as a resource for others within the company for clinical trials management expertise.
10. Able to examine functional issues from an organizational perspective.
11. Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development.
12. May contribute to development of abstracts, presentations and manuscripts.
13. Under supervision, may design scientific communications within the company.
14. Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
15. Must have a general, functional expertise to support SOP development and implementation.
16. Travel may be required.

KNOWLEDGE:

1. Excellent teamwork, communication, decision-making and organizational skills are required.
2. Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
3. Working knowledge and experience with Word, PowerPoint and Excel.

SKILLS:

1. At least 5+ years of experience and BS/BA in a relevant scientific discipline OR
2. At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred.
3. 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.

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.