Clinical Affairs Manager – Part-Time

🕒 April 27

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Aegis Ventures

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11 - 50 employees

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.

📋 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