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Medical Director/Sr. Medical Director (Preclinical, Early Clinical Development)

If interested and qualified, please include Requisition # 2018-339 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

We seek an accomplished Physician to develop translational and clinical plans for our lead programs in hematology and other therapeutic areas.

 The successful candidate will be responsible for strategic development and tactical implementation of the early clinical studies for our lead programs.  This will include providing direct medical/physician oversight for phase 1 and proof of concept clinical trials, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics.  The ideal candidate will have a thorough understanding of the principles of pharmacology, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans, and experience working closely with clinical operations. 

Responsibilities

  • Understand (and eventually develop into local expert for) the underlying scientific principles of the disease indications and pipeline molecules being studied
  • Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy, and IND enabling studies to develop optimal translational medicine approaches to facilitate development to clinical POC
  • Contribute to the development of robust product development plans for each program, including providing content for clinical development and other sections, as needed
  • Identify and establish relationships with leading KOL’s and principal investigators, including organizing and running KOL meetings, as needed
  • Organize and present at relevant clinical advisory boards and medical/scientific meetings
  • Develop protocols and oversee clinical trials as a medical monitor
  • Collaborate with clinical operations to ensure clinical development program success
  • Contribute to the development of regulatory strategy and act as the medical expert in meetings with regulatory authorities
  • Ensure and support effective leadership, management and governance, and seamless collaboration across all areas of Research and Development
  • Serve as the Sponsor’s medical representative to external collaborators
  • Travel, as needed, nationally and internationally

Minimum Qualifications

  • A medical degree (MD or equivalent), current or past board certification in hematology or oncology, and a minimum of 3 years of experience in the pharmaceutical or biotech industry
  • Medical monitor experience in early clinical development, or clinical translational medicine
  • Experience with regulatory activities in US and EU, as well as direct experience with IND filing required;
  • Fluent English, excellent written and verbal communication skills with successful presentation capabilities
  • Ability to travel on average 20% of the time (range 0-30% each month)
  • Ability to work in a team-oriented environment
  • Scientifically rigorous, highly organized, and with significant attention to detail

Preferred Qualifications

  • Experience of setting up and maintaining Statistical Process Control models for systems with highly variable inputs
  • Ability to establish network of key contacts within industry to ensure current and future compliance with expectations from regulators and other interested parties
  • Experience managing outsourced process development, testing, and manufacturing projects
  • Ability to share and apply knowledge in support of technical challenges
  • Strong technical networker
  • Excellent interpersonal/communication skills and team player

Competencies

  • Collaborative One Team.
  • Undaunted – Fearless. Can-do attitude.
  • Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
  • Entrepreneurial Spirit – Proactive. Ownership mindset.

If interested and qualified, please include Requisition # 2018-339 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.