Organization: Raymond A. Wood Foundation
Location: Remote (U.S.-based preferred)
Type: Contract / Consultant (Part-time to start, potential to expand)
About the Project
The Raymond A. Wood Foundation is leading the development of an innovative blood sodium monitoring device designed to improve the lives of patients with complex endocrine conditions, including arginine vasopressin deficiency.
The project is currently in Phase 1 (feasibility and early validation), supported by prior funding from the NIH SBIR program (via Giner, Inc.) and the Raymond A. Wood Foundation.
Development is being conducted in collaboration with Giner, Inc. and clinical partners from Children’s Hospital of Philadelphia, with additional technical and regulatory partners to be engaged.
The device is intended for both point-of-care and at-home use, with the goal of enabling more proactive, real-time management of sodium balance.
The project is entering a critical stage focused on prototype refinement, regulatory strategy development, and positioning for next-stage funding and clinical validation.
We are seeking an experienced Project Lead to guide cross-functional execution, align stakeholders, and help move the device from concept to commercialization.
Role Overview
The Project Lead will serve as both strategic operator and execution lead across technical development, regulatory strategy, legal, and funding workstreams.
This individual will be expected to drive progress, define structure in ambiguous areas, and take ownership of advancing the program toward clear milestones.
The ideal candidate brings experience leading medical device programs from early-stage development through FDA engagement and can translate complex regulatory and technical pathways into actionable plans.
Key Responsibilities
Project Leadership and Execution
- Develop and manage an integrated project plan, timeline, and milestones
- Track progress across all workstreams and ensure accountability
- Identify risks early and drive mitigation strategies
- Lead regular project updates and stakeholder coordination
Cross-Functional Coordination
Serve as the primary point of coordination between:
- Giner Labs (device development partner)
- Children’s Hospital of Philadelphia (clinical partner)
- Regulatory consultants
- Foundation leadership
- Legal counsel
Ensure alignment across technical, regulatory, and strategic priorities
- Partner with an external regulatory consulting firm to define and refine the FDA pathway (e.g., 510(k), De Novo, or HDE)
- Lead overall regulatory strategy direction, ensuring alignment between consultants, technical teams, and foundation leadership
- Guide preparation for early FDA engagement (e.g., Q-submission planning and execution) in collaboration with regulatory partners
- Identify key regulatory risks and required evidence for clearance, and ensure these are integrated into development and clinical plans
- Translate regulatory guidance into clear, actionable requirements for device development, validation, and clinical strategy
Note: A regulatory consulting partner is currently being engaged. This role will be responsible for ensuring that regulatory strategy is cohesive, actionable, and aligned with overall program goals.Budget and
Milestone Management
- Develop and maintain a clear, milestone-based budget
- Ensure funding is tied to defined deliverables and progress
- Identify gaps, inefficiencies, or risks in current plans
Funding Strategy Support
- Support development of investor-ready materials, including:
- Project plans
- Budget and use of funds
- Risk and mitigation framework
- Translate technical and regulatory concepts into clear, compelling narratives
Commercial and Strategic Alignment
Help define and align on product strategy, including point-of-care and at-home use cases, ensuring regulatory and development decisions support both pathways where appropriate.
Qualifications
- 7–15+ years of experience in medical device development
- Proven experience leading products through FDA regulatory pathways (510(k), De Novo, and/or HDE)
- Experience managing cross-functional teams and external partners
- Strong understanding of:
- Clinical development and study design
- Regulatory strategy and FDA interaction
- Product development lifecycle (prototype → commercialization)
- Experience working with early-stage or emerging technologies preferred
- Ability to operate in a fast-moving, ambiguous environment
Preferred Experience
- Background in in vitro diagnostics (IVD) or point-of-care devices
- Experience with small patient populations or rare diseases
- Experience supporting fundraising or investor communications
- Familiarity with nonprofit or mission-driven organizations
Key Attributes
- Highly organized and execution-focused
- Strong communicator who can translate across technical and non-technical teams
- Proactive and comfortable taking ownership
- Strategic thinker with attention to detail
- Able to balance urgency with thoughtful decision-making
Engagement & Compensation
- Contract role (initial 3–6 months, with potential to extend)
- Estimated 15-25 hours per week to start
- Hourly rate expected to range from $125–$200/hour, depending on experience and depth of regulatory and device leadership expertise.
Success in the First 90 Days
Within the first 90 days, success in this role would include:
- Development of a clear, integrated project plan with milestones across technical, regulatory, and funding workstreams
- A defined regulatory strategy direction, including FDA pathway recommendation and Q-submission plan
- Alignment across partners (Giner, CHOP, consultants) on roles, responsibilities, and next steps
- Identification of key technical and regulatory risks, with mitigation strategies
- A refined budget and milestone-based funding plan aligned to the next development phase
- Contribution to positioning the project for next-stage funding (grants, investors, or partnerships)
This role is expected to bring structure, clarity, and forward momentum to a complex, early-stage initiative.
To Apply
Lead the strategy and execution needed to move a first-of-its-kind sodium monitoring device from early development toward regulatory clarity and next-stage funding.
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