Careers

Exec Medical Director/VP Clinical Development

Location: San Mateo or Cambridge

POSITION

Reporting to the Chief Medical Officer, the ED/ VP of Clinical Development will be responsible for the planning, conduct and analysis of clinical trials with Kronos Bio development candidates and for shaping the development strategy for these assets. The ED/VP of Clinical Development works directly with other Development functions including Clinical Operations, Regulatory Affairs, Translational Science, Biometrics and Data Management to develop GCP compliant study protocols and associated regulatory documents, identify potential investigators and sites, design electronic data capture forms, perform periodic data listings reviews and working with Drug Safety, ensure that all adverse events are investigated and reported to relevant authorities in a timely manner. As a key member of the molecule Project Core Team, the ED/VP of Clinical Development will leverage the cross-functional expertise of Discovery Research, Development functions and Commercial Strategy to generate a plan from IND enabling studies through First-in-Humans trials, Clinical Proof of Concept and registration trials. As appropriate and based on experience, the individual will provide input on translational and clinical considerations to inform the Discovery pipeline.

ESSENTIAL FUNCTIONS AND DUTIES

  • Drives clinical development strategy including (but not limited to):
    • In collaboration with the Core Team Lead and cross-functional team members, generate a comprehensive clinical development plan (CDP) for the asset that addresses dose and schedule selection, clinical proof of concept and registration plans
    • Represent the CDP at governance meetings for major resourcing decision points
  • Clinical trial design and implementation including (but not limited to):
    • Protocol development from concept/synopsis to full protocol
    • Translational plan (in collaboration with the Translational Science Lead)
    • Data capture forms and statistical analysis plan (working with Data Management and Biostatistics)
  • Analyze and interpret data, and clearly communicate results both internally and externally
  • Ongoing medical monitoring of clinical trials including data listings review
  • Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
  • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders.  These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy.
  • Working collaboratively with Medical Writing, Drug Safety, Clinical Operations, Commercial, and Regulatory Affairs
  • Mentoring junior staff, and providing guidance and opportunity for their professional development

SKILLS AND EXPERIENCE

  • M.D., Ph.D. or D.O. with clinical training in adult or pediatric oncology
  • Minimum of 8 years of experience in clinical development with a track record of successfully executed Phase 1 and 2 cancer trials with targeted small molecule drugs. Experience with registrational trials and NDA filing a plus
  • Current in depth understanding of cancer biology and molecular genetics as they apply to the rational development of targeted anti-cancer drugs
  • Excellent verbal and written communication skills and an ability to distill complex concepts for presentation to both technically sophisticated and non-technical audiences
  • 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.