Vice President, Clinical Affairs
Karius
Redwood City, CA, USA · United States · Remote
Posted on Tuesday, April 16, 2024
About Karius
Karius has pioneered the use of microbial cell-free DNA metagenomic sequencing for diagnosis and management of infectious diseases and other diverse applications. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, and to ultimately reduce patient suffering worldwide.
Position Summary
We are looking for an experienced Vice President for Clinical Affairs to lead our clinical operations and development teams to support clinical evidence generation, new product development, and regulatory submissions. The Vice President of Clinical Affairs will report to the Chief Medical Officer and will be a key leader in design (Development) and execution (Operations) of product and clinical evidence generation, and regulatory efforts. The successful candidate will make or recommend operational strategies in support of achieving clinical program objectives and be responsible for design and management of clinical evidence generation, including managing clinical sites, vendors, and collaborating with internal and external stakeholders.
Why Should You Join Us?
Karius is revolutionizing the diagnosis and management of infectious diseases through multiple innovations including microbial cell-free DNA signal processing, metagenomic sequencing, and bioinformatics including use of advanced machine learning and artificial intelligence. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Chief Medical Officer
Location: Redwood City, CA or Remote
Primary Responsibilities:
• Lead all clinical operational aspects of a clinical trial from protocol, clinical agreements, start-up, training, maintenance, and close-out.
• Lead the clinical development strategy to design a dynamic and fast- paced road map to prioritize clinical indications and accelerate test adoption.
• Contribute to development and responsible for maintaining study-related plans and documents including clinical study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, protocol deviation plans, case report forms, clinical study reports (CSRs), clinical sections of regulatory documents, briefing books, safety updates and responses to Health Authorities' questions.
• 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 the development and assessment of program level feasibility, forecasting of timelines, estimation and allocation of resources and budget, and development of operational strategies.
• Develop and manage a departmental budget including oversight of planning, forecasting and monitoring.
• Contribute to a Clinical Development Plan (CDP) that meets the strategic objective of the company and is approved by appropriate approval/governance bodies.
• Attract, hire, develop and mentor a high performing clinical affairs team that embraces challenges and values innovative problem-solving with a commitment to organizational success.
• 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.
• 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.
• Be responsible for working with multiple clinical partners and vendors to complete clinical trials.
• 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.
What’s Fun About the Job?
Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
Travel: Travel required up to 20%.
Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels. Work is generally performed in an office, lab, or clinical environment.
Position Requirements
• Minimum Bachelor's in scientific or clinical field. Ph.D. or M.D. with relevant clinical experience, including leadership roles in clinical microbiology, antibiotic stewardship and/or infectious disease (ID) medicine, preferred.
• 10+ years clinical management experience and 5+ years experience in hospital, clinical laboratory, and/or life science markets with a successful track record of well-executed clinical studies.
• Experience with Medical Device-IVD, 510K/PMA and/or lab-developed test diagnostic clinical trials, preferred.
• Strong personnel management experience and leading teams that include Clinical Study Managers, Clinical Data Managers, and Statisticians.
• Strong project management experience and best practices.
• Experience in running multi-site clinical trials and clinical site management.
• Working experience with an electronic data capture system, CTMS system, and eTMF system.
• In depth understanding of human subject research, ICH/GCP guidelines and knowledge of FDA/CMS /LDT regulations.
Personal Qualifications
• Demonstrated ability to thrive in a cross-functional environment focused on company-level goals, interact across multiple disciplines, be flexible, and handle multiple tasks to meet deadlines while delivering high-quality work in a dynamic environment.
• Collaborate with cross-functional teams, including medical affairs, regulatory affairs, biostatistics, and data management, to drive clinical development activities and achieve milestones.
• Oversee the preparation of clinical study documents, including clinical protocols, investigator brochures, clinical study reports, and regulatory submissions.
• Develop and implement the clinical development strategy and roadmap in alignment with corporate objectives and regulatory requirements.
• Lead the planning, execution, and oversight of clinical research studies, including protocol design, site selection, patient recruitment, and data analysis.
• Manage relationships with key opinion leaders, clinical investigators, and external partners to support clinical trial activities and enhance scientific credibility.
• Demonstrated ability to manage outside consultants, vendors, and contractors.
• Thinker and doer with the ability to formulate, develop, and execute clinical strategies.
• Provide clinical input and expertise to support product development, including protocol development, study design, and regulatory submissions.
• Monitor clinical trial progress and performance metrics, identify risks and issues, and implement mitigation strategies to ensure timely completion of clinical studies.
• Represent the company in interactions with regulatory agencies, clinical trial sites, and scientific conferences to communicate clinical data and support product registration and commercialization efforts.
• Mentor and develop clinical affairs team members, providing guidance, support, and professional development opportunities.
• Outstanding scientific written and oral communication skills as well as interpersonal, organizational, and project management skills.
• Strong business acumen and use of business analytics to prioritize, lead and influence.
• Excellent analytical and abstract reasoning skills.
• Demonstrated ability to identify, motivate, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees, and are committed to honor and invest in the full diversity of people, in our hiring, recruiting, and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.