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 experienced Director of Clinical Operations to lead the overall execution of clinical programs. The Director of Clinical Operations will report to the Chief Medical Officer and will play a key hands-on leadership role in the planning and execution of all clinical development programs and studies, managing personnel and activities across the organization. S/he will make or recommend operational strategies and/or decision in support of achieving clinical program objectives and is accountable for the functional management including recruiting, building and maintaining a high-quality Clinical Operations team.
· Contribute to the development and assessment of program level feasibility, forecasting of timelines, estimation and allocation of resources and budget, and development of operational strategies.
· Maintain an overview of status, issues, risks and proactively communicates progress, issues, changes or risk mitigation strategies that may impact timelines and costs of the program to all stakeholders.
· Contribute to a Clinical Development Plan (CDP) that meets the strategic objective of the company and is approved by appropriate approval/governance bodies.
· Partner closely with the medical and clinical teams to plan and execute clinical studies to produce high-quality data for publications while satisfying regulatory requirements.
· Be responsible for working with multiple clinical partners and vendors to complete clinical trials.
· Manage a clinical operations team, which includes creating standard operating procedures, aiding in IRB submission, clinical study monitoring, and data acquisition. Oversees the teams work to ensure all department goals, deliverables, and objectives are met.
· Evaluate and implement optimal outsourcing models. Lead the operations team in the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution and ensure proactive management of CRO to deliver within established timelines, budget, and quality expectations.
· Develop and implement processes across all operations functions and ensure proactive inspection readiness. Ensure adherence to ICH GCP and applicable guidelines and regulations.
· Develop a data management strategy for clinical studies that allows for easy data abstraction and analysis, collaboration and interaction with R&D and production lab systems, analytics and data security.
· Contribute to authoring clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents, briefing books, safety updates and responses to Health Authorities' questions.
· Travel: 10%
· Minimum Bachelor’s in in scientific or clinical field. Medical background and advanced degree, preferred.
· 5 - 7 years of experience in clinical operations in a pharmaceutical company or biotech/life sciences firm. Experience across all phases of clinical development. Proven ability to lead a multidisciplinary team toward a successful outcome.
· Experience with IVD or diagnostic clinical trials, preferred.
· Strong personnel management experience.
· Strong project management experience and best practices.
· Experience in running multi-site clinical trials, including data management systems.
· In depth understanding of GCP regulations and knowledge of other regulatory guidelines.
· Demonstrated ability to work in a fast-paced, life sciences company environment, interact across multiple disciplines, and manage outside consultants, vendors and contractors.
· Excellent interpersonal, communication, negotiation, organizational and influencing skills.