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Medical Director, Clinical Development

Jobleads.com
Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

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, andcancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling.Essential Job Duties/Responsibilities:

  • 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 roof 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 inmeetings with the regulatory organizations or key opinion leaders, establishment of strategy
  • Working collaboratively with Medical Writing, Clinical Operations, Commercial, and Regulatory Affairs
  • Provides Drug Safety medical oversight and evaluation of events for safety reporting
  • Mentoring junior staff, and providing guidance and opportunity for their professional development
Education/Experience/Skills:
  • M.D., Ph.D. or D.O. with training in adult or pediatric oncology
  • Minimum of 5 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
The expected annual salary range for this full-time position is $255,000 - $300,000, plus eligibility for bonus, benefits, and equity incentives. Actual pay will be determined based on experience, qualifications, business needs, internal equity, and alignmentwith 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 requiredof employees assigned to this position. #J-18808-Ljbffr

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