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Sr Clinical Director- Medical Diagnostic IVD and 510K experience

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).

We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.

The Job

This is a critical job for our growing company and one that works in close partnership with our clinical partners, scientific staff, and C-level leadership. As the clinical study and regulatory leader, you will have overall responsibility for these mission-critical functions. The role spans strategy, planning, management of clinical trial execution, building strong internal and external relationships, managing clinical sites, and collaborating with our scientific, quality system teams.

This is both a management and a hands-on role that serves as the lead of clinical studies, including performing on-time with defect-free execution; ensuring timelines are being met in clinical studies (i.e. recruiting, data management, statistics); organizing study initiation meetings to plan the execution of the study; facilitating study review meetings for pre-study, in-process, and post-study review; problem-solving as needed during study conduct; meeting with clients as needed throughout the study, and organizing study logistics and personnel. The job includes:

  • Leading all clinical operational aspects of a clinical trial from protocol, clinical agreements, start-up, training, maintenance, and close-out.

  • Preparing study-related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision.

  • Oversight of global clinical research organizations (CROs) and vendors to ensure the trial is executed per the protocol and within timelines and budget by monitoring all vendor activities.

  • Providing oversight of regional monitors and/or CRO.

  • Establishing and maintaining strong relationships and communication with sites and site staff.

  • Ensuring Trial Master File is current and maintained, proper site training and management, ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations.

  • Execute clinical studies and 510(k) approvals.

  • Contributing to EDC set-up, case report form design, user acceptance testing, completion guideline development, and other related activities.

  • Identifying any potential risks to the study timelines and/or conduct, and acting on mitigations.

  • Selecting, developing, and evaluating personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.

  • Providing direction to PI’s, Clinical Research Managers on staffing needs, funding, and resources in order to meet the needs of individual research efforts and overall research group.

  • Clarifying and resolving issues with substantial significance and impact, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge.

  • Providing direction for the clinical sites to establish protocol development. Reviewing clinical practices, case report forms, and reports.

You

You have a successful track record of well-executed clinical studies and three or more 510(k) submissions. You are self-driven, capable of figuring out what needs to be done and making it so. You should be excited by the prospect of working in a dynamic, entrepreneurial environment.

  • Must have Medical Device-IVD and 510K experience

  • You are a strategic thinker with the ability to formulate, develop, and execute clinical strategies.

  • You can develop and manage relationships with clinical key opinion leaders and lab directors worldwide.

  • You are adept at discussing the science and research approaches that are critical for study protocol design, clinical endpoints, and data interpretation.

  • You have excellent scientific written and oral communication skills as well as interpersonal, organizational, and project management skills.

  • You are flexible and adaptable to the needs of a young, mission-driven company.

  • You are prepared to run a high-quality research organization, organizing and motivating teams who perform basic science research and clinical research.

  • You have working experience with an electronic data capture system, CTMS system, and eTMF system.

  • You have people and project management experience of clinical sites and leading teams of direct reports that include Study Managers and Data/Statisticians.

  • Strong interpersonal communication (written and verbal), organizational, and prioritization skills.

  • Able to work effectively in a fast-paced and changing environment. Strong work ethic and demonstrated ability to deliver assignments on time.

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