Clinical Affairs Lead

Searching for an Opportunistic Clinical Affairs Lead Most Clinical Affairs postings want someone who can run the standard playbook. We want someone who can write a new one, legally and rigorously, when the standard one doesn't exist yet. We are a well-funded, late-stage medical device startup with our sights set on saving lives. We have FDA-cleared, non-invasive hardware sensors that acquire patients' vital signs anytime, anywhere. We have some great products and some great ideas, validated by the US Military, SOCOM, NATO, the Gates Foundation, the Cleveland Clinic, and many others. Our device saved its first life 2 months after our first FDA clearance and we're now up to seven. I'd love to go into more details here, so we can find the best possible candidate, but we have confidentiality issues to contend with. That will have to wait until we sign an NDA and have a cup of coffee. We're looking for a leader to manage and execute our upcoming clinical trials, owning the FDA regulatory strategies and their execution, along with the design, planning, and execution of human clinical trials. We have processes, procedures, product history, and talent in place today. We also have multiple Q-Subs and 510(k)s in the works, along with designed protocols from our government partners that will need to be executed. Details will have to wait until that virtual cup of coffee, but we need to use our funding intelligently and creatively to accomplish the testing of individuals at rest and in motion, healthy and unwell. You should be intelligent, creative, adaptable, and able to juggle lots of concepts at once. We're looking for someone whose friends comment that they never forget or lose track of anything, someone who learns things quickly and retains that knowledge. A great attitude goes a long way! You must also be a problem-solver. You must also be ambitious, self-motivated, and equally able to work independently or in groups. You must also be an effective communicator and able to learn from and work with clients and teammates. The ideal candidate would have knowledge and experience in wearable technology and working with the FDA, IRBs, the Department of War, or the federal government. A bonus would be someone who comes in with thoughts and ideas about project management and accomplishing goals and objectives. What we're really looking for is someone who is smart, ambitious, and can keep track of lots of things at once. You must also be able to learn quickly and apply what you've learned; you also need to be able to concentrate on both the forest and the individual trees at different times. Ultimately, we're looking for aptitude and not decades of experience. We need someone to roll up their sleeves, but this is the kind of role that will most likely morph into a leadership role in the next few years. There may be some travel, but we can locate our trials to your general area over time. Since we are a startup, everyone has diverse roles and no two days are ever the same. If you like to punch the clock and do the same things every day, this role is probably not for you. We have lots of great resources on staff to learn from. Our company culture is having fun while working hard to save lives. We are well-funded with awards and budgets for these activities, but the answer cannot be just outsourcing each clinical trial. We require creativity to bridge the gap between existing medical device predicates and the science of today. These trials must follow best practices and all laws, but we will be forward-thinking in terms of risk management and strategy to best accomplish our objectives. Confidence is good. I want someone who is confident in their abilities and doesn't let things get in the way of the positive things they can contribute. These qualities usually lean towards a positive-leadership style. We believe very strongly in surrounding ourselves with the best and brightest, so should you. Hopefully, you know who you are and are already planning to respond to this based upon what you've read so far. If so, please respond to this posting with your resume so we can get you in the door and on a very promising path. Responsibilities Own the end-to-end FDA regulatory strategy, from Q-Sub meetings through submissions, for a fast-moving portfolio of non-invasive vital-sign sensors. Design, plan, and execute human clinical trials and human factors studies, including protocols built with government and military partners. Facilitate FDA and IRB interactions and filings, and keep both moving without becoming the bottleneck. Translate unconventional testing conditions (new environments, new populations, tight timelines) into protocols that are rigorous, defensible, and fully compliant. Manage clinical trial budgets and vendor/CRO relationships, using funding creatively rather than defaulting to full outsourcing. Grow the clinical affairs function as trials scale: this role is expected to move into a leadership position within a few years. Requirements and Qualifications Bachelor’s Degree in a related scientific / technical field. Expert Clinical Affairs best practices and legal precedent knowledge. 3-4+ years of hands-on FDA and/or IRB experience with increasing responsibility, ideally including clinical trials and/or human factors testing. Functional knowledge of statistical analyses and reporting. High native intelligence: fast learner, sharp pattern recognition, retains detail without being reminded. Genuine creativity: comfortable finding compliant, defensible ways to execute unconventional testing scenarios, not just the standard playbook. Working knowledge of wearable or sensor technology and clinical affairs best practices. Project management experience strongly preferred. Exceptional communication and interpersonal skills: genuinely easy to work with, low-ego, and builds trust quickly with teammates, clients, and government partners. Strong self-motivation: productive and disciplined working from home without oversight. Excellent organization, memory, and attention to detail: nothing falls through the cracks. Time management and the ability to juggle multiple concurrent workstreams. Problem-solving orientation, focused on business objectives over process for its own sake. Office 365 proficiency. Claude or another AI-based LLM experience is a plus. ** No offshore resources or hiring agents need respond. You would predominantly work remotely with few trips per year. The primary location is San Diego, CA; Washington, DC metro area; Austin, TX; or San Antonio, TX. Other considerations may be given to individuals located in Texas, Georgia, Idaho, Pennsylvania, Maryland, Delaware, Virginia, or California. #J-18808-Ljbffr Sempulse