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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.
Sr Clinical Trials Manager
Location
United States
Posted
100 days ago
Salary
0
No structured requirement data.
Job Description
Sr Clinical Trials Manager
Kite Pharma
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role involves managing international clinical trials and ensuring adherence to program budgets and timelines. - In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials. - Coaches members of a work team and ensures adherence to established guidelines. - Provides input to program budget and timelines. - Anticipates obstacles and client difficulties and implements solutions to achieve project goals. - Assists CPM in revising project timelines/budgets as necessary. - Works with management on departmental issues, providing input to clinical operations strategies and work plans. - Communicates with functional peers regarding project status and issues. - Contributes to development of abstracts, presentations, and manuscripts. - Participates in the recruiting and hiring process for CPA/CRAs and supports their professional development. - Participates in training of CPAs and CRAs. - Provides guidance and training to CROs, vendors, investigators, and study coordinators on study requirements. - Excellent interpersonal skills and demonstrated ability to lead is required. - Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. - Strong communication and influence skills and ability to create a clear sense of direction is necessary. - Must have a demonstrated ability to successfully develop, implement, manage, and complete clinical trials. - Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. - Experience in developing RFPs and selection and management of CROs/vendors. - Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision. - Functional expertise to initiate, author, or contribute to SOP development, implementation, and training. - Travel is required. Qualifications - 8+ years of experience and a BS or BA in a relevant scientific discipline OR - 8+ years of experience and an RN (2 or 3 year certificate). Requirements - Ability to examine functional issues from a broader organizational perspective. People Leader Accountabilities - Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. - Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. - Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. Benefits - The salary range for this position is: $143,225.00 - $185,350.00. - This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. - Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Job Requirements
- 8+ years of experience and a BS or BA in a relevant scientific discipline OR
- 8+ years of experience and an RN (2 or 3 year certificate).
- Ability to examine functional issues from a broader organizational perspective.
- People Leader Accountabilities
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.
Benefits
- The salary range for this position is: $143,225.00 - $185,350.00.
- This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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