VP, Clinical Affairs | Karius

VP, Clinical Affairs

About Karius
Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body.  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, to ultimately reduce patient suffering worldwide.
Position Summary
We are looking for a seasoned VP, Clinical Affairs to lead our clinical development, clinical operations and scientific communication teams. This role is a key leadership position who will provide strategy and vision for leading our clinical research.
Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. 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 Scientific Officer
Location:           Redwood City, CA
Primary Responsibilities
●     Lead the clinical development strategy to design a dynamic and fast-paced road map to prioritize clinical indications and accelerate test adoption.
●     Create and execute a strategy for multiple study plans aligned with commercial strategy, regulatory requirements and corporate goals.
●     (Translate a product development strategy and requirements into effective implementation and delivery of all clinical studies adhering to programmatic timelines with efficient use of resources.)
●     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.
●     Develop a clinical network of key opinion leaders with expertise in translational medicine and infectious disease to help guide clinical development and medical affairs strategies.
●     Develop and manage a departmental budget including oversight of planning, forecasting and monitoring.
●     Manage and expedite clinical operations study documents, including material transfer agreements, master study agreements, strategic collaborations, and key vendor services.
●     Provide clinical leadership with respect to technology and strategy in collaborations with internal functional teams.
●     Develop and manage a clinical evidence dossier, including a well-planned series of publications based on clinical study data, to ensure effective communication of test technologies and clinical performance.
●     Develop and organize a document control system, including study protocols, clinical trial documentation, and standard operating procedures (SOPs) for Clinical Operations, to align with current and evolving quality and regulatory requirements.
●     Develop and manage Medical Affairs activities designed to communicate scientific and clinical value propositions for clinical education and test adoption through diverse communication channels, including scientific meetings and medical conferences.
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 25%.
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
●     Ph.D. or M.D. with relevant clinical experience, including leadership roles in clinical microbiology, antibiotic stewardship and/or infectious disease (ID) medicine.
●     10+ years clinical management experience and 5+ years experience in hospital, clinical laboratory, and/or life science markets.
●     Served as a Principal Investigator or in other clinical research leadership roles at diagnostics clinical trial sites; or have directed Clinical Affairs or Clinical Operations for ID companies conducting clinical trials.
●     Strong publication record in respected journals related to clinical microbiology, pathology, infectious disease, etc.
●     Thought leader in the field as evidenced by speaking invitations, journal editorial positions and/or professional society leadership roles.
●     A strong track record of hiring, assessing, training and developing high performing teams.
●     Understand the needs and decision processes related to new technology adoption and reimbursement at the level of the laboratory, hospital / IDN as well as CMS and private payers.
Personal Qualifications
●     Passionate, purpose-driven, and excited about Karius’ mission.
●     Excellent written and verbal communication and organization skills, with an analytical and problem solving mindset.
●     Ability to effectively collaborate with peers in other functions and with team members in other functions.
●     Ability to define problems, gather data, establish facts, and draw valid conclusions and recommendations.
●     Strong business acumen and use of business analytics to prioritize, lead and influence.
●     Excellent analytical and abstract reasoning skills.
●     Role model for Karius culture and values.
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.

Redwood City, CA