Job

{
  "request": {
    "pageUrl": "https://www.pathai.com/careers/DirectorClinicalOperations-6715804002",
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    {
      "requirements": [
        "Experience in histologic-based or other medical imaging in a regulated environment is strongly preferred."
      ],
      "diffbotUri": "job|3|1793551482",
      "type": "job",
      "title": "Director, Clinical Operations",
      "remote": "REMOTE",
      "skills": [
        {
          "salience": 0.7316089,
          "skill": "DDT",
          "confidence": 0.6169359,
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      "humanLanguage": "en",
      "employer": {
        "name": "PathAI",
        "diffbotUri": "https://diffbot.com/entity/EIf6kAhRvMq2mBsM6DV2Krw"
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      "pageUrl": "https://www.pathai.com/careers/DirectorClinicalOperations-6715804002",
      "locations": [
        {
          "country": {},
          "address": "Boston, Massachusetts",
          "city": {},
          "subregion": {},
          "latitude": 42.36027908325195,
          "precision": 15.231546401977539,
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          "longitude": -71.05777740478516
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      ],
      "text": "Who We Are\nPathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.\nWhere You Fit\nThe Director of Clinical Operations will be responsible for programmatic tactical execution of regulated research and clinical products, including companion diagnostic (CDx), non-CDx-IVD, Drug Development Tools (DDT) and RUO strategies. This is a highly matrixed role that requires outstanding emotional intelligence combined with detailed subject matter expertise in order to help coordinate the program across all functional areas including quality, clinical, business development, scientific programs, engineering and product teams. The Director of Clinical Operations will bring together all stakeholders internally and externally to successfully design, execute on all aspects of our clinical development programs. Outstanding detailed organizational skills with a proactive mindset toward identification of all programmatic risks and mitigations is essential.\nWhat You’ll Do\nLead the execution of research and clinical development strategies for new clinical trial, research, and medical device product development, and operationalize these strategies from development to commercialization.\nAccountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan, including adherence to quality, timelines and budget.\nEstablish and continually communicate detailed program and project plans with critical paths and dependencies clearly identified across each area and communicate timeline progress and risks through defined operating mechanisms.\nEducate relevant leads from each functional area on the regulations impacting development programs.\nClearly communicate strategy, progress, and risks cross functionally and proactively drive/facilitate the relationship between internal project teams and external stakeholders.\nEffectively prioritize the projects within our clinical development programs to ensure adequate resourcing and efficient delivery on priority projects for PathAI.\nInform leadership of any identified gaps, risks, solutions to the program as a whole.\nWhat You Bring\nOur employees' skills come in all shapes and sizes, but to be successful in this role with us, you'll at least need:\nPh.D (preferred) or M.S. in a Life Science or equivalent field, plus at least 5-7 years of relevant industry experience, including at least 3 years in a role of primary responsibility for clinical trial execution and management.\nYou have a solid understanding of and experience in drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs.\nDirect management experience and supervisory responsibility.\nYou have knowledge (training preferred) of the software development life cycle (IEC 62304), design control, and experience in leading in vitro diagnostic development teams.\nYou have supported projects for FDA and other regulatory body submissions from development to validation to approval.\nYou have cross therapeutic area clinical biomarker testing and diagnostic testing experience in global clinical trials.\nYou have experience and a deep understanding of biomarker testing and reporting requirements globally.\nYou excel in leading multidisciplinary teams of scientists and engineers in highly matrixed organization is strongly preferred\nYou are a strategic thinker, pro-active and agile, and you have a strong interest in bringing teams together at PathAI, as well as external partners, to bring better treatments to patients.\nExperience in histologic-based or other medical imaging in a regulated environment is strongly preferred.\nWe Want To Hear From You\nAt PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for.\nPathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.\n#LI-Remote\n",
      "datePosted": "Sat, 07 May 2022 00:00:00 GMT",
      "tasks": [
        "Lead the execution of research and clinical development strategies for new clinical trial, research, and medical device product development, and operationalize these strategies from development to commercialization.",
        "Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan, including adherence to quality, timelines and budget.",
        "Establish and continually communicate detailed program and project plans with critical paths and dependencies clearly identified across each area and communicate timeline progress and risks through defined operating mechanisms.\n",
        "Educate relevant leads from each functional area on the regulations impacting development programs.\n",
        "Clearly communicate strategy, progress, and risks cross functionally and proactively drive/facilitate the relationship between internal project teams and external stakeholders.",
        "Effectively prioritize the projects within our clinical development programs to ensure adequate resourcing and efficient delivery on priority projects for PathAI.\n",
        "Inform leadership of any identified gaps, risks, solutions to the program as a whole.\n",
        "Ph.D (preferred) or M.S. in a Life Science or equivalent field, plus at least 5-7 years of relevant industry experience, including at least 3 years in a role of primary responsibility for clinical trial execution and management.",
        "You have a solid understanding of and experience in drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs.\n",
        "Direct management experience and supervisory responsibility.",
        "You have knowledge (training preferred) of the software development life cycle (IEC 62304), design control, and experience in leading in vitro diagnostic development teams.",
        "You have supported projects for FDA and other regulatory body submissions from development to validation to approval.",
        "You have cross therapeutic area clinical biomarker testing and diagnostic testing experience in global clinical trials.",
        "You have experience and a deep understanding of biomarker testing and reporting requirements globally.",
        "You excel in leading multidisciplinary teams of scientists and engineers in highly matrixed organization is strongly preferred",
        "You are a strategic thinker, pro-active and agile, and you have a strong interest in bringing teams together at PathAI, as well as external partners, to bring better treatments to patients.\n"
      ]
    }
  ]
}