Medical Director/Sr. Medical Director (Preclinical, Early Clinical Development)
We seek an accomplished Physician to develop translational and clinical plans for our lead programs in oncology 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.
- 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
- A medical degree (MD or equivalent), current or past board certification in oncology, and a minimum of 3 years of experience in the pharmaceutical or biotech industry
- Medical monitor experience in clinical development, or clinical translational medicine
- Experience with regulatory activities in US or ex-US EU, as well as direct experience with IND or CTA 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
- Collaborative – Openness. 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.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.