Director, Combination Product Program Lead

The role

You will drive a drug-device combination program from device design and verification through risk management and design history file ownership. You will lead the FDA regulatory strategy and act as the technical link between pharmaceutical development and device engineering.

What you will do

• Drive the drug device combination program end to end
• Shape the FDA regulatory strategy for the combination product
• Translate between pharmaceutical development and device engineering
• Align and mobilize multidisciplinary colleagues across Praxis
• Interface with technology partner and direct external consultants
• Perform hands-on technical problem solving in electronics, software, electrochemistry, and delivery hardware
• Present progress, risks, and decisions to executive leadership

Required qualifications

• Personally led technical development of a drug-device combination product
• Experience in device design and engineering, verification and validation, human factors, and combination product risk management
• Experience taking devices or combination products through FDA regulatory processes
• Background or experience in working in electrical engineering projects
• Working understanding of pharmaceuticals and devices
• Knowledge of combination product quality systems (ISO 13485)
• Knowledge of risk management (ISO 14971)
• Knowledge of human factors / usability engineering (IEC 62366)
• Knowledge of on-body / wearable delivery system requirements (ISO 11608, including Part 6)
• Knowledge of medical electrical equipment safety (IEC 60601)
• Ability to lead people and programs while delivering technical work
• Ability to coordinate diverse specialists and work with external partners

Nice to have

• Electronics and embedded hardware design
• Software / firmware development
• Electrochemistry as applied to delivery or sensing
• Human implantable or body worn device development
• On-body, wearable, or transdermal delivery device development
• Direct ownership of a combination product design history file (DHF), technical file, or design control documentation, end to end

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans
• 401(k) matching up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.