Clinical Affairs Manager – Part-Time

🕒 April 27

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Aegis Ventures

WebsiteLinkedInAll Job Openings

11 - 50 employees

🤖 Artificial Intelligence

🏥 Healthcare

Artificial Intelligence • Healthcare

Aegis Ventures is a next-generation startup studio that partners with entrepreneurs and industry leaders to originate, launch, and scale transformative companies. The Aegis platform brings together market-shaping ideas, permanent growth capital, and ambitious individuals who are driven to solve major societal problems. Aegis aims to build companies with the capacity for vast impact, focusing initially on artificial intelligence and health technologies to improve healthcare quality, access, and cost.

📋 Description

• 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

🎯 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

🏖️ 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