Senior Clinical Trials Manager, Clinical Operations - Early Development

Location
Foster City
Salary
See job description.
Posted
March 26 2021
Ref
R0018042
Position Type
Full Time
Organization Type
Pharma
Job Type
Project Manager


Senior Clinical Trials Manager, Clinical Operations - Early Development
United States - California - Foster City

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. Gileads 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 companys five core values. Thats 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


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 Operations 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.

Senior Clinical Trials Manager, Clinical Operations - Early Development (Sr. CTM)

Specific Responsibilities and Skills for Position:
  • Ability to write study protocols, study reports, and sections of investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision
  • In partnership with the assigned Clinical Program Manager (CPM), provides guidance and daily oversight to ensure the successful management of all aspects of clinical trials within designated program budgets and timelines
  • Independently manage less complex study(s)
  • Communicates with functional peers regarding project status and issues and ensures project team goals are met
  • Ability to resolve problems using national and international regulations, guidelines, and investigator site staff interactions
  • Provides guidance and training to Clinical Research Organizations (CROs), vendors, investigators and other site staff on study requirements
  • Anticipates obstacles and implements solutions to achieve project goals applying previous knowledge and experience
  • Experience in developing Request For Proposals (RFP) and selection and management of CROs/vendors
  • May contribute to the development of abstracts, presentations and manuscripts
  • Provides functional expertise to contribute to standard operating procedures (SOP) development, implementation and training
  • Participates in the recruiting and hiring process for Clinical Project Assistants/Clinical Trial Mangement Associates (CPAs/CTMAs) and supports their professional development
  • May manage CPA/CTMA/Sr. CTMA
  • Coaches members of a work team and ensures adherence to established guidelines
  • Travel may be required


Knowledge:
  • 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
  • Excellent interpersonal skills and demonstrated ability to lead is required
  • Excellent verbal, written, interpersonal and presentation skills are required
  • Ability to lead a cross-functional team and drive performance
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary
  • Ability to examine functional issues from a broader organizational perspective


Experience and Skills:
  • At least 7+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
  • At least 5+ years of experience and a Masters' degree or higher; scientific discipline preferred

For jobs in the United States:

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. 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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' 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 log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Senior-Clinical-Trials-Manager--Clinical-Operations---Early-Development_R0018042-1





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