Director, Combination Product Program Lead
Core
Lead the end-to-end development of a novel drug-device combination product pairing proprietary therapeutics with an advanced dermal delivery platform.
Role type
Senior Program Leader (Combination Product) (via careerplan.io/jobs/5381250008-director-combination-product-program-lead-at-praxisprecisionmedicines)
Builds
A clinical-stage drug-device combination product for dermal delivery
Domain
Biopharmaceuticals / Medical Devices / Drug Delivery Systems
Required skills
Drug-device combination product technical leadership, FDA regulatory strategy, Electrical engineering, Pharmaceutical development, Device engineering, Risk management (ISO 14971), Quality systems (ISO 13485), Human factors engineering, Cross-functional team leadership, Executive communication
Preferred skills
Electronics and embedded hardware design, Software/firmware development, Electrochemistry, Implantable or wearable device development, Direct ownership of Design History File (DHF)
Technologies
FDA 21 CFR Part 4, ISO 13485, ISO 14971, IEC 62366, ISO 11608, IEC 60601
Responsibilities
Own the program from device design and verification through risk management and design history file ownership; Lead the regulatory pathway and shape FDA strategy; Bridge drug and device development; Unite a multidisciplinary team; Partner externally with technology partners and consultants; Contribute hands-on to technical problem solving in electronics, software, and electrochemistry; Communicate progress and risks to executive leadership
Seniority
Senior, hands-on IC with program leadership