Clinical Program Manager, Clinical Operations - Oncology
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, Morris Plains, NJ, Seattle, WA or remotely in the US. Strong preference to be office based.
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 impletementation 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
For Colorado Job Applicants: The salary range for this position is:
$143,600.00 - $215,400.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
For jobs in the United States:
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