Clinical Program Manager, Clinical Operations - Oncology
Clinical Program Manager, Clinical Operations - Oncology
United States - California - Foster CityUnited States - Washington - Seattle
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 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 Program Manager, Clinical Operations - Oncology (CPM)
We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team. The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment. This position can be located in Foster City, CA or Seattle, WA.
Specific Responsibilities and Skills for Position:
- Team leader and builder who provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines Must have a demonstrated ability to successfully develop, implement, manage, and complete clinical trials.
-Partners with cross functional teams to manage, adjust, and revise project timelines and budgets
- Communicates project status and issues and ensure project team goals are met; escalates issues appropriately within the organization- Experience in selection and management of CROs/vendors, including the development of RFPs
- Ability to write study protocols, study reports, and regulatory documents (e.g. IND, NDA, PRAC, etc.) with little supervision
- Recruits, hires, mentors, and manages Clinical Project Assistants through Sr. Clinical Trials Managers as direct reports or skip levels and supports their professional development. Experience line managing staff, including mentoring and developing team members at a variety of levels is required
- Anticipates moderately complex obstacles and difficulties and implements solutions to achieve project goals; displays strong risk assessment capabilities and implementation of mitigation strategies
- Resolves issues within national and international regulations and guidelines.
- Strong communication and influencing skills to be used cross-functionally within the organization as well as with vendors and investigational sites, as appropriate.
- Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision. Examines functional issues from a broader organizational perspective. Functional expertise to initiate, author, or contribute to SOP development, implementation and training
- Contributes to development of abstracts, presentations, and manuscripts
- Travel is required
- Excellent interpersonal skills and demonstrated ability to lead is required
- Strong communication and influencing skills and ability to create a clear sense of direction and purpose is necessary
- Thorough knowledge and understanding of FDA and EMA Regulations (as well as other or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and non-interventional studies
Experience and Skills:
- At least 8+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
- At least 6+ years of experience and a Masters' degree or higher; scientific discipline preferred
- Prior oncology (specifically in solid tumors) clinical trials experience is preferred
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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