About Kronos Bio

Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets. We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling.

Summary of Position

The Senior Clinical Trial Manager, Clinical Operations is responsible for the planning, successful implementation, and management of one or more clinical trial(s). The Senior Clinical Trial Manager provides operational leadership to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions (WIs). The Senior Clinical Trial Manager applies critical thinking skills for problem solving and has the lateral and strategic thinking capacity to drive their assigned studies with effective communication across the organization. The Senior Clinical Trial Manager demonstrates strong drive in applying innovative approaches to accelerate drug development.

 

Essential Duties and Responsibilities:

  • Has accountability and oversight for assigned studies and ensures they are carried out in accordance with the protocol, SOPs, ICH/GCP regulations, and study-specific manuals and procedures
  • Provides study oversight, leadership, and support to Contract Research Organization (CRO) and staff to ensure overall delivery at the country and site level for all operational activities (e.g. study management, site monitoring, specifications development, UATs, issues escalations, etc).
  • Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverables
  • Assists in the development and/or review of study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, etc.
  • Participates in clinical service provider (vendor) selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities including leading the vendor teams through strong partnership/collaboration and inspiration
  • Participates in the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors
  • Participates in continuous site engagement with all levels at the site to increase the visibility and enrollment of trial
  • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
  • Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
  • Proactively manages/identifies potential study issues/risks and works with leadership to recommend/implement solutions with key internal/external stakeholders
  • Compiles, maintain, and communicates regular study progress status reports and study timelines Leads and/or participates in internal team meetings, investigator meetings, and other trial specific meetings
  • Participates in the development, review, and implementation of departmental SOPs, WIs, initiatives and processes
  • May manage/mentor direct reports and team members, and perform performance appraisals as assigned
  • Reviews/approves vendor invoices and provides oversight for payment of clinical trial vendors and investigative sites
  • Performs other work-related duties as assigned
  • Has a strong drive to apply innovative approaches into drug development

 

Qualifications:

  • BA/BS or equivalent degree in scientific discipline.
  • Minimum years of clinical trial research management experience in pharmaceutical or biotechnology: 5 years for Senior CTM level
  • Experience in managing outside vendors, e.g., CROs, other clinical trial vendors, and/or investigational sites
  • Ability to travel approximately 50% of the time
  • Strong team player
  • Advanced understanding of clinical research and able to work effectively in a team/matrix environment
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a Clinical Development Plan
  • Experience in oncology preferred
  • Experience in global trials preferred
  • Embodies Kronos values; exhibits high degree of integrity and professionalism when interacting with outside investigators and vendors
  • Entrepreneurial and enjoys working in a fast-paced, creative and resourceful small company environment

The expected annual salary range for this full-time position is $130,000 - $160,000, plus eligibility for bonus, benefits, and equity incentives. Actual pay will be determined based on experience, qualifications, business needs, internal equity, and alignment with market data

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.                                                                       

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