Director, Research Business Management, Kite Research Strategic Operations

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 14, 2020
Ref
R0015340
Required Education
Associate Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite, a Gilead Company, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. 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. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Director, Research Business Management, Kite Research Strategic Operations (Director, Project Management)

Responsibilities (include but are not limited to):

  • Provide Research Teams with business management leadership and insights in business strategy and process to guide and organize operations.
  • Research Business Management is an integral part of Research Strategic Operations, working closely with lab management, project management, strategic planning and external collaboration functions to provide strategical and operational expertise to enable the advancement of our sciences.
  • Direct the biological sample management requirements Research and Translational Medicine at RDMC-West, including clinical trials within and across development programs
  • Support team members and empower them to complete deliverables efficiently and effectively.
  • Collaborate with Clinical Operations and Translational Medicine to develop a compliant system for biological sample tracking and issue resolution
  • Support the development of Research strategy and plan according to Research Governance, including project planning and necessary scenario development, planning and analysis.
  • Provide guidance in the development and review of biomarker-related content within study protocols and support development of informed consent forms
  • Organize and manage Research team meetings, as assigned, ensuring timely, efficient, and action-oriented operations.
  • Collaborate with Clinical Operations and Translational Medicine to develop processes for proposals, budget review, vendor selection, review and development of the scope of work/laboratory services specification documents and site-facing laboratory manuals
  • Work in partnership with clinical and project leads and functional leads, to develop, identify risks and opportunities, implement corrective actions and execute on the operational plan and strategy.
  • Develop, install, validate, and manage operations of a Kite Research Laboratory Information Management System (LIMS) that meets all regulatory requirements
  • Oversee Research external collaboration contracting process
  • Direct Business Management for external collaborations, CROs and vendors supporting Research and all associated contracts, regulatory requirements and logistics with the partners when necessary.
  • Understanding of GLP/GCP requirements in support of clinical programs
  • Direct communications for Research Business Management and ensure that all stakeholders (internally and externally) are fully informed and knowledgeable of project activities and their status.
  • Liaise with cross-functional and functional stakeholders (e.g. Program Manager, CMC Program Manager, Alliance Manager, Legal and Regulatory representatives etc.) to execute on cross-functional deliverables and resolve issues.
  • Implement best-in-class operations management processes and tools/templates such as project schedules, Gantt charts, action/decision logs, risk registers, SharePoint site etc.
  • Contribute to specimen- and vendor-related non-clinical and clinical study deliverables for IND and BLA filings.
  • Provide inputs on behalf of Business Management for the LE process.
  • In addition, contribute to Research Governance and Portfolio Management activities, such as:


Prepare agenda, minutes, and action items for Research governance meetings Maintain SP site and documents associate with Research governance Provide training and communication of Research governance process Manage Research governance calendars Support Research portfolio reviews Prepare routine and/or ad hoc project status/dashboard reports

Requirements:

12+ years of relevant experience in oncology and a BS in immunology/cell biology or related fields or; 10+ years of relevant experience and a MS in immunology/cell biology or related fields or MBA; 8+ years of relevant experience and a PhD in immunology/cell biology or related field or a PharmD, DVM or MD degree. A solid scientific background is a must. Relevant experience consists of work in a scientific field or equivalent experience in association with Research, Translational Sciences/Medicine, R&D project teams and/or in cross-functional project management activities.

  • Must have extensive understanding of discovery research, translational sciences/medicine and pre-clinical development and overall drug development process.
  • Must have extensive experience in applying principles, concepts, practices, and standards of pharmaceutical project management in Research and/or Translational Sciences/Medicine.
  • Must have familiarity with GLP and GMP regulations and the practical application to biological specimen management
  • Prior experience in cellular therapy, synthetic biology, oncology research greatly preferred.
  • Exemplify our core values - integrity, accountability, team work, excellence and inclusion.
  • Must possess excellent interpersonal, organizational, written and verbal communication skills along with ability to work collaboratively in a team environment.
  • Must be able to effectively communicate progress toward milestones, opportunities, and risks to all stakeholders.
  • Must exhibit high emotional intelligence, with demonstrated ability to successfully negotiate through challenging situations and difficult conversations.
  • Possess a strong ability to build trust, along with demonstrated ability to drive, lead and influence colleagues across the organization to achieve team, department and corporate goals.
  • Must be a team player, focusing on shared goals, being flexible and applying skills where required, respecting others, listening to others' views and value others' contribution, sharing information and good ideas across organizations and celebrating/recognizing accomplishments.
  • Must have strong leadership skills and ability to effectively develop teams and coach others.
  • Must be comfortable and efficient in a fast-paced, dynamic and growing environment.


Location:

Santa Monica, California

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. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.