Director – Combination Product Program Lead
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Job Description
Director leading Praxis’s drug-device combination product toward clinical development. Coordinating FDA strategy, engineering, and cross-functional teams for CNS therapies.
Responsibilities:
- Drive the drug-device combination program end to end from device design and verification through risk management and design history file ownership
- Set strategy, build integrated timelines, manage risk, and maintain scope, quality, and deadlines
- Shape the FDA regulatory strategy while coordinating device and drug considerations
- Keep the program inspection ready and submission ready at every stage
- Translate between pharmaceutical development and device engineering so both advance in lockstep
- Align and mobilize scientific, regulatory, quality, clinical, and operations teams across disciplines and seniorities
- Serve as the day-to-day interface with the technology partner
- Direct and integrate external device and regulatory consultants
- Perform hands-on technical problem solving across electronics, software, electrochemistry, and delivery hardware
- Present progress, risks, and decisions to executive leadership
Requirements:
- Personally led the technical development of a drug-device combination product spanning device design and engineering, verification and validation, human factors, and combination product risk management
- Experience taking specific combination products or delivery systems from early development through design transfer, submission, or launch
- Demonstrable FDA device regulatory experience, including 21 CFR Part 4, design controls, and premarket submissions
- Background or experience in electrical engineering projects or a closely related field, with genuine technical depth
- Working understanding of pharmaceuticals and devices and how they come together
- Knowledge of combination product quality systems (ISO 13485), risk management (ISO 14971), human factors/usability engineering (IEC 62366), on-body/wearable delivery system requirements (ISO 11608, including Part 6), and medical electrical equipment safety (IEC 60601)
- Evidence of leading people and programs while also delivering technical work personally
- Ability to coordinate diverse specialists and work with external partners and consultants
- Comfort and credibility presenting to and being challenged by senior leadership
- Highly desirable technical breadth in electronics and embedded hardware design, software/firmware development, electrochemistry, implantable or body-worn device development, wearable/transdermal delivery device development, or combination product DHF/technical file/design control documentation ownership
- Comfort operating iteratively, adapting quickly, and making progress amid ambiguity
- Ability to build trust across organizations, take ownership, follow through, give and receive direct feedback, and work with urgency while maintaining quality and compliance
Benefits:
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance
- Company-paid AD&D
- Disability benefits
- Voluntary plans to personalize coverage
- Dollar-for-dollar 401(k) matching up to 6% on eligible contributions
- Long-term stock incentives
- ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns
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