Clinical Lead

Clinical LeadVitaKey is an exciting start-up developing and commercializing proprietary technology for controlled, targeted, extended, and sustained delivery of macronutrients, micronutrients, probiotics, biologics, small molecules, etc. to be included in everyday foods and beverages to improve human health. We are seeking innovative and motivated scientists and engineers to be part of the company's next-phase of growth at our Durham NC HQ. Learn more about our company on our website at  Role SummaryResponsibilities will involve building, leading, designing, and executing on VitaKey clinical programs for evaluating VitaKey platform technologies. Responsibilities will also include working in an interdisciplinary role with formulation scientists, manufacturing engineers, business team members, and potentially leading and managing teams of 2+ clinical research associates. You will serve as an independent contributor and team lead simultaneously, and have the opportunity to build a clinical program team. Projects will be highly interdisciplinary, at the intersection of engineering, biochemistry, materials science, food science and nutrition. Duties and ResponsibilitiesIdentify, evaluate, select, and manage interactions with clinical CRO partnersDesign, compile, and present clinical trial outlines for evaluating nutrient pharmacokinetics, organoleptic properties, biodistribution, fate and function, and other clinical outputs of VitaKey formulationsCombine knowledge from formulations, manufacturing, and clinical outcomes to enable design and implementation of clinical studies that demonstrate competitive advantages of VitaKey formulationsDesign trials to support nutrient health claimsEstablish needs for overseeing clinical trials for VitaKey formulations to ensure timelines and deliverables are metPerform necessary clinical statistical analysis such as power analyses, epidemiological modeling, PK/PD analysis, etc.Define and execute long term vision for the clinical programs at VitaKeyTravel (~10% of time) to clinical CRO partners to oversee and lead CRO selection and clinical trialsWork with scientists within the group and with external laboratories, and present ideas and resultsMay mentor and direct other team members QualificationsMS with a minimum of 8-12 years of experience or PhD with minimum of 5-8 years of experience in industry or academia in designing and overseeing clinical trials in the nutrition and consumer goods spaceCandidates who have direct experience designing, overseeing, and summarizing 2+ nutrient or nutraceutical human clinical trials are preferredCandidates with experience using trial data to generate health claims for nutritional or personal care products are preferredExperience working with professionals from formulation science, chemical engineering, bioengineering, pharmaceutical sciences, polymer chemistry, food science or allied disciplinesExperience conducting power analyses, epidemiological modeling, PK/PD analysis, etc.Experience with complex statistical analyses to support trial design and evaluation of resultsExperience designing clinical trials evaluating pharmaceuticals, nutraceuticals, medical devices, proteins, carbohydrates, polymers, microparticles, probiotics, and/or lipids for health and/or performance outcomesEntrepreneurial and self-motivated work style; comfort in ambiguityExcellent cross-disciplinary skills in communicating ideas to both scientists and non-scientistsStartup experience is highly valued, but not required.Ability to adjust rapidly to changing scientific priorities and technologies

Created: 2025-06-05