Daniel Hansen Email & Phone Number

Santa Monica, California, Us

- Contribute to Product and Program Strategy as Kite Clinical Operations representative on the anitocabtagene autoleucel (CART-ddBCMA) Product Team (PT) and Global Research and Development Team (RDT)- Accountable for the operational strategy and successful execution of the clinical development plan with quality, including financial accountability. - Act as a leader of leaders with a focus on employee engagement, development and team health. - Accountable for resource management, including ongoing assessment of resource needs and optimal deployment of resources. - Lead cross-functional organizational change initiatives and strategy. - Serve as the point of escalation for assigned programs and initiatives.- Provide matrix management and leadership to study teams and external vendors across a broad portfolio of clinical studies.- Own and manage budgets and resource plans for assigned therapeutic area.- Balance people development, employee engagement, operational excellence / innovation and portfolio delivery.- Accountable for balancing clinical development plan execution with detailed oversight at the study-level; has strong visibility into study status and provides coaching and guidance to others as needed.

Santa Monica, California, Us

- Lead highly complex projects and enable multiple functions, teams, and cell therapy clinical programs to achieve their objectives within targeted timelines and allocated resources. - Responsible for managing people leaders and multiple larger-scale study teams.- Act as a process improvement and innovation champion by identifying opportunities to enhanceoperational excellence and innovation and staff to drive initiatives.- Actively consult on short- and long-term strategy and operational plans, including consistent messaging upon implementation.- Interact and partner with cross-functional leaders to ensure the right clinical study strategy and direction to achieve desired outcomes. - Champion Kite's Leadership Commitments and Values with an appropriate balance of portfolio delivery, resource management, and organizational excellence / innovation while being able to effectively manage more complex assignments.- Extract consistently high-quality results through others and optimized approach to assigned work. - Determine how to structure and manage assigned studies across programs to ensure project deliverables are completed on-time, within-budget and to the quality expected. - Use advanced communication skills to optimize project team and stakeholder relationships.- Develop change management skills in other team members by providing proactive change management leadership and guidance.- Develop and maintain strong stakeholder relations as evidenced by consistently positive stakeholder feedback.- Lead highly visible, largely cross-functional strategic initiatives

Santa Monica, California, Us

- Lead and oversee efforts to organize first in-person department face-to-face meeting since COVID (approximately 100 in-person and virtual participants)- Serve as Clinical Operations SME on cross-functional working group to transform Kite's clinical study drug supply platform with goal to automate critical steps in the cell therapy logistics process, improve efficiencies, reduce compliance risks, and deliver the best customer experience focused on product cycle transitions- Serve as Clinical Operations lead for working group responsible for developing and maintaining updates to the Kite protocol template- Partner with Kite/Gilead Development Business Operations to serve as a change champion for new vendor performance issue management system (VIMS) process- Serve as a small group facilitator for the Kite Leadership LIFT lab (cohorts for senior manager and associate director level people managers) and GMentor program- Represent Kite Clinical Operations on cross-functional virtual trial category review leading to the selection of preferred eCOA, telehealth, and home health vendors- Lead the development of study protocols, study reports, and regulatory documents (e.g. IND, NDA, etc.)- Contribute to the development of abstracts, presentations, and manuscripts- Provide guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines- Responsible for the recruitment and management of Clinical Operations staff as well as mentoring and developing junior staff- Partner with cross functional teams to manage, adjust, and revise project timelines/budgets as necessary- Experience developing RFPs and selection and management of CROs/vendors- Functional expertise to initiate, author, or contribute to SOP development, implementation and training

Santa Monica, California, Us

- Lead cross-functional working groups to develop master cell therapy Long Term Follow-Up (LTFU) protocol in line with company’s strategic objectives- Represent Clinical Operations on cross-functional protocol development and virtual trial (eConsent, telehealth, eCOA, etc) category review workstreams- Prepare and review study-related and essential clinical study start-up documents, including clinical protocols, ICFs, IBs, and other relevant study plans and charters)- Participate in study strategy development, Line Listing Review, and Clinical Study Report preparation- Manage the study project plan, timelines and budget- Work with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met- Manage CRO interactions, including sponsor oversight of operational functional activities - Proactively identify potential study issues/risks and implement solutions.- Participate in the selection, training and evaluation of study personnel to ensure the efficient operation of the function. - Prepare and present program- and study-level metrics updates to senior management- Organize and manage internal team meetings, investigator meetings and other trial-specific meetings- Serve as a liaison and resource for investigators and site personnel- Participate in the development, review and implementation of departmental SOPs and processes- Provide mentorship and career development to direct reports.

Thousand Oaks, Ca, Us

- Lead the operational strategy and management of complex, early-stage, first-in-human (FIH) and adaptive/innovative design program in multiple myeloma through oversight of cross-functional activities applying Fastlane® principles- Represent the clinical operations team at Evidence Generation Team (EGT) meetings, provide input into the Clinical Development Plan (CDP), and evaluate feasibility of strategy for business-critical programs- Collaborate with Early Development Lead (EDL) to review study data for and conduct Dose Level Review Meetings (DLRM) and to ensure effective implementation of DLRM recommendations- Conduct regular engagement with key investigators to facilitate open dialogue between study team and sites regarding status, issues, and responses of current study subjects, as well as potential subjects, slot assignments, and protocol design considerations- Contribute to the authoring of protocols and amendments, relevant sections of annual safety reports (DSUR), clinical study reports (CSR), pharmacy manuals, site training documents, and drive timelines to completion- Engage with investigators and Key Opinion Leaders (KOLs) at conferences and congresses to advance scientific exchange and collaboration between Amgen and the medical community- Oversee third-party vendors and functional service providers (FSP) to ensure quality performance and adherence to scope of work within outsourcing specifications, and timelines- Manage trial budget, investigate discrepancies, and maintain program finances to the required standards- Serve as core member of the Early Oncology Portfolio (EOP) Forum to align cross-functional roles, identify gaps and training needs, and ensure quality through the implementation of fit-for-purpose solutions across the portfolio- Developed and co-lead half-day training program for Regional Clinical Trial Managers (RCTMs) to present key EOP updates and facilitate discussion between Amgen Early Development team and regional FSP team

Foster City, Ca, Us

- Manage geographical regions of large complex clinical trials- Manage and maintain cross functional timelines- Draft and coordinate review of protocols, informed consent forms (ICFs), case report forms (CRFs), monitoring plans, investigator brochures (IBs), and clinical study reports (CSRs)- Coordinate review of data listings and preparation of interim/final CSRs- Assist in determining the activities to support project priorities within clinical operations- Contribute to the development of RFPs and participates in selection of CROs/vendors- Train CROs, vendors, investigators and study coordinators on study requirements- Contribute to the development of study budgets- Serve as a resource for others within the company for clinical trials management expertise- Examine functional issues from an organizational perspective- Participate in the recruitment and hiring process for CPAs and CTMAs and support their professional development- Contribute to development of abstracts, presentations and manuscripts- Participate in strategic initiatives across the organization, including SOP development and implementation

Foster City, Ca, Us

- Work with Clinical Program Managers to manage processes of oncology and inflammation/respiratory clinical trials- Partner with Clinical Program Managers and Managers in other functions, providing input where key decisions impacting business operations will be made.- Delegate tasks to direct reports with the ability to coordinate and allocate responsibilities based on complexity of work and skill set of CPAs and CRAs.- Provide strategic guidance of junior staff given acute insight on the monitoring of clinical sites.- Actively involved in solving critical issues, applying previous knowledge to meet schedules.- Manage CRAs and CPAs while supporting their professional development.- Provide guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.- Coach members of a work team and ensure adherence to established guidelines.- Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.- Anticipate obstacles and client difficulties and implement solutions to achieve project goals.- Contribute to development of abstracts, presentations and manuscripts.- Participate in the recruiting, hiring, and training process for CPA/CRAs and support their professional development.- Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

Portland, Oregon, Us

- Manage a team of 10 research staff and oversee all personnel-related activities for the Phase 1, melanoma, thyroid, and GIST programs, with direct oversight of clinical trials involving newly-developed compounds for use in the fight against various cancers.- Lead research staff in the planning and coordination of over 70 clinical trials involving drugs used in the treatment of a wide range of cancers, with responsibility for the development and implementation of comprehensive standardized operating procedures and systems.- Contribute to the development and review of study budgets of up to $1 million with responsibility for ensuring compliance with laws, regulations, and policies related to clinical research billing.- Evaluate up to 20 potential studies per year based on scientific merit, OHSU's access to patients, and the Knight's available resources, and select studies that develop ongoing relationships with industry partners and further the Knight's goal of becoming an NCI-designated Comprehensive Cancer Center by 2016.

Portland, Oregon, Us

- Used LEAN methodologies to identify and eliminate waste in the clinical trial start-up process, reducing the average start-up time from 125 to 55 days, and opening new relationships with industry partners who were previously hesitant to open trials at OHSU.- Identified and implemented a number of process improvements, including a new process for scheduling research-related tumor biopsies that reduced the number of people involved, allowed procedures to be scheduled faster, and improved the quality of material available to scientists for important research.- Screened and interviewed new research project personnel, including several hires who went on to become managers and major contributors within the organization.

Portland, Oregon, Us

- Managed clinical and regulatory activities for 10 Phase 1 research projects, including several first-in-human studies involving targeted therapies and immunotherapies.- Grew the new Phase 1 program from 10 accruals in 2011 to 50 in 2014, with continued involvement in the program's expansion to becoming one of the Knight's top enrolling groups, with almost 70 annualized accruals currently.

Portland, Oregon, Us

- Acted as a liaison between local review boards, investigators, project research personnel, and industry sponsors to ensure uninterrupted operation of and successful completion of research projects.- Held accountable for managing regulatory aspects of more than 50 ongoing projects.

Portland, Oregon, Us

- Assisted with clinical and regulatory aspects of multiple research projects.

Mba, Management

B.S., Psychology