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Sr. Medical Director, Immuno-Oncology

If interested and qualified, please include Requisition # 2018-300 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

We are seeking an accomplished Physician Scientist to join our exciting, fast growing, dynamic and well financed new company, to develop translational and clinical plans for our lead immune oncology programs 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, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics; translating the mechanism of action and preclinical pharmacology studies into the clinical pharmacology of our phase 1 and proof of concept clinical trials, and providing direct medical supervision and monitoring for clinical studies. The successful 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. The position requires enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.

Responsibilities

  • Understand (and eventually develop into local expert for) the underlying scientific principles of the disease indications and pipeline molecules be 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
  • Develop optimal translational medicine strategy to demonstrate clinical pharmacology and POC in patients in early stage clinical trials
  • 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 KOLs and principal investigators, including organizing and running KOL meetings, as needed
  • Develop (and where appropriate, with clinical operations), protocol synopses and protocols, consent forms, Investigator Brochures and other materials, as needed
  • Oversee clinical trials as medical monitor, review patient eligibility and enrollment and clinical trial data on an ongoing basis
  • Oversee and review ongoing data
  • Review and approve clinical study reports
  • Collaborate with biometrics and clinical operations to ensure operational and 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

Minimum Qualifications

  • MD and 3 years’ experience in the pharmaceutical or biotech industry in both preclinical and early clinical development, or clinical translational medicine
  • Experience in the development of biologics
  • Experience in Clinical Pharmacology or significant understanding of the principles of pharmacology as well as nonclinical (toxicology) requirements for testing new therapies in humans.
  • Strong scientific research and clinical training required;
  • Ability to travel (range 0-20% each month).
  • Excellent oral and written communication skills
  • Ability to work in a team-oriented environment
  • Scientifically rigorous, highly organized, and with significant attention to detail

Preferred Qualifications

  • MD and 5+ years of life sciences industry experience
  • Expert knowledge of Cell and Gene Therapy (or Advanced Therapy Medicinal Product) product development, within industry, helpful; experience in orphan product development helpful
  • Experience with regulatory activities in US and EU, as well as direct experience with IND filing required; additional experience with NDA filing helpful
  • Fluent English, excellent written and verbal communication skills with successful presentation capabilities required
  • Deep knowledge of Immuno Oncology preferred

Competencies

  • Scientific Rigor/Attention to detail – Maintains high scientific rigor and attention to detail in designing and testing hypotheses and analyzing data. Challenges assumptions, demonstrates highly organized thinking and documentation
  • Creativity/Innovation - Creates a boundary-less environment that fosters curiosity and taking risks, is able to test, confirm or refute scientific hypothesis effectively and efficiently. Open to new approaches, alternative points of view and methodologies. Able to be opportunistic
  • Results Oriented – Drives issues to closure and gets the job done
  • Risk and Compliance Management – Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies
  • Leadership – The ability to take the role as a leader of a team or work group; the desire to lead others
  • Communication and Teamwork – Effectively expresses ideas in written, visual, and oral context. Able to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals
  • Passion - Creates an exciting environment where there is a true passion for the vision of CRISPR Therapeutics to bring novel medicines to patients suffering from serious diseases
  • Results Orientation / Productive Work Habits – Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns / utilizes resources effectively and efficiently

If interested and qualified, please include Requisition # 2018-300 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.