Careers

Sr. Director – VP, Clinical Operations

Location: San Mateo, CA

POSITION

Under the general supervision of the Chief Medical Officer, the Senior Director/VP, Clinical Operations will provide, direction, and oversight for all operational aspects related to the planning, execution and analysis of clinical studies with Kronos Development compounds from pre-IND through registration trials. Responsibilities include design of departmental objectives related to Clinical Operation deliverables, selection and management of service providers and clinical trial sites, supervision of ethical and good clinical practices, supervision of clinical trials within the programs, development of clinical relationships with partners of the corporation, including interactions with third-party CROs, corporate partners, and physicians. As the clinical stage portfolio grows, the Sr Director/VP Clinical Operations will be responsible for building an internal Clinical Operations function through hiring.

ESSENTIAL FUNCTIONS AND DUTIES

  • Provide leadership to the Clinical Operations Group from pre-IND/CTA (Phase 1 planning) through the completion of the Phase 3 clinical program, NDA submission and preparation for any post-application regulatory.
  • Timely delivery of key Clinical Research objectives, including clinical trial datasets suitable for analysis and if appropriate, regulatory.
  • Contribute to the operational, safety and administrative design of clinical trial protocols, and oversee the implementation of protocols to meet required objectives ensure implementation of high standards of research conduct in compliance with clinical guidelines and regulations; oversee development and implementation of clinical staff development and training.
  • Work as part of a cross-functional team to assist in developing strategic direction for a product development plan; identify and propose potential new research or development projects and assess the feasibility of pursuing these.
  • Develop and/or oversee the preparation of specific clinical portions of project regulatory submissions such as Investigator Brochures, Clinical Study Reports, Development Safety Update.
  • Develop and/oversee the budget for department; advise and assist company with clinical expense budget, cost forecasting, and resource.
  • Conduct and/or oversee the evaluation of vendors and negotiate contracts; manage third-party CROs and other external partners.
  • Liaise with individuals and groups within the organization for purposes of information, communication, training, and collaborative work.
  • Work with contacts outside the company including Clinical Investigators and Research Groups, Consultants, Corporate Partners, Key Opinion Leaders, Contract Research organizations, and other vendors as necessary; Represent company at presentations to external parties as requested or necessary.
  • Responsible for periodic updates to Senior Management.
  • Develop processes and SOPs for operational aspects of clinical drug development.
  • Recruit, supervise and develop Clinical Operations department personnel as the clinical portfolio grows.
  • May perform other duties as assigned or as needed.

SKILLS AND EXPERIENCE

  • This position requires in life or hard sciences.
  • A minimum of ten years clinical research and drug development experience in the pharmaceutical/biotech industry is preferred.
  • Demonstrated project planning, managerial, organizational, and leadership skills in a dynamic start up environment running multiple trials through an outsourcing model at U.S. and ex-U.S. clinical sites.
  • Work effectively in a cross-functional environment and as part of an overall product development team.
  • Demonstrated experience focused on clinical investigation, clinical operations, clinical trial data integrity, drug safety reporting, clinical compliance, and financial reporting.
  • Strong working knowledge of US and international regulatory requirements and excellent knowledge of ICH/GCP and FDA guidelines; excellent planning, organizational and execution skills; must be results driven.
  • Maintains a high level of professional expertise through familiarity with clinical literature.
  • Supervisory experience managing a clinical team for a minimum of 5 years.
  • Excellent oral (including presentation skills) and written communication skills.
  • Proven organizational and project management skills and ability to handle multiple diverse projects simultaneously; Strong problem-solving skills, attention to detail, and flexibility to adapt in a growing organization.
  • Strong interpersonal skills and a leadership style that provides timely coaching, guidance and feedback to assist others in their individual or group performance
  • Ability to travel when needed.
  • 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.

To apply for this position, please forward your resume and cover letter to careers@kronosbio.com.