Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed. Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.
We are looking for an outstanding physician executive to strategically guide the company as we build on our market leadership to establish the value of sequencing-based diagnostics within infectious disease. The Chief Medical Officer (CMO) is responsible for the strategy, direction and execution of the company’s clinical development plans and will provide strategic leadership in developing the evidence necessary to achieve widespread adoption, reimbursement, incorporation into society guidelines, and regulatory approval. The CMO has direct responsibility for Clinical Development, Clinical Operations, Medical Affairs, and Regulatory Affairs.
We seek someone to provide medical leadership in the executive team as we build future products to solve some of the toughest problems in infectious diseases.
· Guide overall evidence development strategy to support reimbursement, protocol integration, and regulatory approvals, including guidance regarding clinical utility and health economic/outcomes research studies
· Provide medical and clinical leadership in future product development
· Lead the Clinical Development and Operations teams in the planning and execution of studies
· Lead the Medical Affairs team in educating physicians, payers, regulators in the value of the Karius Test
· Represent the medical/clinical perspective in board meetings, investor meetings, regulatory and medical communities, pharmaceutical and collaborators/partners and other meetings with key stakeholders
· In collaboration with the CSO and CTO, provide key guidance for the development of new products and features
· Monitor competitive landscape closely and assist company in responding to competitive threats
· Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
· Doctoral-level degree in the Life Sciences (MD or DO) is required
· 10 years minimum of experience in clinical diagnostics, medical device, or pharmaceutical/biotechnology industry
· Strong publication record in support of product clinical adoption, reimbursement or integration into society guidelines.
· Comprehensive understanding of the diagnostic and device regulatory landscape including Lab-Developed Tests and In-Vitro Diagnostics
· Demonstrated clinical executive leadership as evidenced by strong track record of driving multiple successful project advancements
· Proven experience in developing and managing the clinical strategy aligned with operating plans and budgets
· Strong track-record of recruiting and leading high-performing cross-functional teams that value collaboration including the ability to develop talent
· Network of strong relationships within your professional communities
· Experience interacting with CMS, private payers
· Expertise in scientific and clinical data review and interpretation
· Outstanding communication skills including public speaking, media interviews, written communication, and interpersonal skills
· Excellent judgment, initiative, and problem-solving skills