Sr. Director, Laboratory Operations And Clinical Development
Greater Minneapolis-St. Paul Area
OneOme is a commercial-stage precision medicine company, co-founded with Mayo Clinic. With a focus on comprehensive pharmacogenomic testing, OneOme is positioned to change the practice of medicine by delivering personalized and actionable insight to guide more appropriate medication selection and avoid potential adverse drug reactions.My responsibilities at OneOme included: ► Served as member of leadership team at a Mayo-backed pharmacogenomics startup, setting business goals and defining company strategy to align with operational success► Designed and deployed a state-of-the-art pharmacogenomics laboratory, with CAP/CLIA accreditation and commercialization of testing within 6 months of hire ► Ramped capacity and testing output with full penetration to all 50 states and over 20 countries within 1 year of full commercial launch; leading to a ~$3.6M run-rate ► Collaboratively supported sales, business development, marketing, and product development teams to deliver on strategic and operational objectives ► Developed cost- and time- efficient strategies to meet key milestones for laboratory inception, panel design, validations, and regulatory accreditations within budget and according to tight deadlines ► Established, implemented, and monitored policies, procedures, and practices for efficient and streamlined operation of the laboratory and clinical development activities, reducing costs and increasing efficiency with continuous improvement► Oversaw appropriate safety, accreditation, and quality assurance programs for laboratory, clinical development, and clinical support operations; proactively addressing risk areas to avoid findings or deficiencies in regulatory inspections ► Led all aspects of clinical and laboratory operations, including oversight of laboratory staff, clinical development staff, clinical support staff, and advisors, including hiring, training, and management of 10 scientists and pharmacists