Aegis Ventures - Clinical Affairs Manager (Part-Time)

Remote - within the U.S.$281k - $281k+ Equity2mo ago

Remote Senior NA Hospitals Medical Devices Clinical Director GCP Data Analysis Business Development

Requirements

• Advanced degree (MSN, MD, or PhD) with 5-10 years experience • Direct experience in obstetrics, neonatal care, or women's health preferred • Understanding of fetal monitoring technologies and labor & delivery workflows preferred • Experience with clinical research, preferably medical device studies • Knowledge of FDA medical device regulations (510k, PMA pathways) • Experience with clinical trial design, IRB processes, and GCP compliance • Track record of successful regulatory submissions or clinical study management • Understanding of biostatistics and clinical data analysis • Medical device or healthcare technology background strongly preferred • Experience working with hospital systems and clinical decision-makers • Understanding of healthcare reimbursement and adoption challenges • Familiarity with quality systems and ISO 13485 requirements

Responsibilities

• Lead clinical study design and execution across multiple hospital sites • Manage relationships with clinical investigators and hospital administrators • Support FDA regulatory pathway including Q-sub preparation and clinical trial protocols • Oversee clinical data collection and analysis for regulatory submissions • Establish and maintain relationships with OB/GYN departments and L&D units • Guide clinical workflow integration and user experience optimization • Support hospital IRB processes and vendor vetting procedures • Lead clinical training and education programs for adoption • Work closely with engineering team on device usability and clinical requirements • Partner with regulatory consultants on FDA strategy and submissions • Collaborate with algorithm team on clinical validation of EEG analysis • Interface with business development on hospital partnership negotiations

Benefits

• Remote-first culture with periodic team gatherings • Healthcare benefits and competitive compensation • Equity participation in breakthrough medical technology • Opportunity to directly impact maternal and neonatal outcomes globally • Collaboration with world-class clinical researchers at Yale, USC, and international partners • $135/hour - $175/hour, depending on experience and alignment with role expectations.