PathAI's mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Rigorous science and careful analysis is critical to the success of everything we aspire to do. Our team, comprised of diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact for patients.
We are looking for a dynamic, experienced Director of Clinical Science, who will report to the Vice President, Clinical Development and Regulatory affairs, to lead design of and execution on PathAI’s clinical strategy, by developing clinical plans, providing scientific support during trials and validation studies, as well as contributing to the analysis of results and writing of clinical study reports. Scientific/medical knowledge, effective people management and clear written and verbal communication and collaboration will be key to success.
What you’ll do:
- Lead the clinical science and operations teams to develop and carry out strategies for each medical device submission and/or fit-for-purpose validation studies for PathAI’s Clinical Trial Services and other internal programs.
- As leader of the Clinical Science function, be the single point of accountability for clinical validation evidence planning for all products, working closely with the Integrated Evidence Lead to ensure strategic alignment.
- Support development and authoring of documents (protocols, study reports) for the clinical aspects of regulatory submissions, with adherence to GCP and/or GCLP guidelines where appropriate.
- Direct the design of clinical plans and protocols, providing a foundation for Case Report Form (CRF) development, training, etc., with our Pathologists and other cross functional team members.
- Work with PathAI Statistical Team to support development and execution of statistical analysis plans to support clinical studies.
- Communicate well and closely collaborate with regulatory, quality, product and other cross-functional teams to effectively design and execute on studies which will help to demonstrate robust performance, safety and effectiveness of PathAI products.
- In collaboration with the Regulatory Affairs function, participate in submission review discussions with FDA and other global regulatory agencies.
What you’ll need:
- Ph.D. or equivalent in a biological or medical field with 7-10 years of experience in clinical science and medical writing, preferably in diagnostics, and experience and/ or knowledge in clinical development for therapeutics.
- Experience with medical device validation studies and regulatory submissions including 510k and PMA in vitro devices (IVD).
- Working knowledge of statistical analysis; ability to work with statisticians to design and execute on statistical analysis plans.
- Experience in digital pathology, radiology or other imaging technology, especially in clinical trials, is preferred.
- Good organizational skills, attentive to details, and able to multitask.
- Strong written, verbal, and presentation skills.
For the right candidate, we'll offer a competitive salary plus equity. Your compensation is rounded out by a strong benefits package:
- Flexible work hours, with work-from-home options available
- Three weeks of paid leave per year, an additional two weeks of sick time, plus extended holidays and team-approved leave
- Ten days of 100% subsidized childcare per year
- Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
- Commuter benefit available for public transit or parking
Most importantly, you'll be doing important work with a team of people you'll genuinely enjoy spending the day with.
PathAI 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.
PathAI does not accept unsolicited submissions from third-parties.
With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.