Clinical Development Lead - Early Research
Listed on 2026-10-03
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Research/Development
Clinical Research -
Healthcare
Clinical Research
Job Summary
ONWARD Medical is building a structured portfolio of Early Clinical Research across its ARC-EX, ARC-IM, and ARC-BCI platforms encompassing Investigator-Initiated Studies (IIS), Early Feasibility Studies (EFS), and grant-funded projects. The Clinical Development Lead – Early Research serves as the operational and scientific backbone of the portfolio and ONWARD’s primary point of contact for external clinical partners. The role translates Marketing’s strategic indication priorities into a focused clinical development portfolio and coordinates each study across its full lifecycle, from initial request and protocol development through execution, data collection, and reporting.
In collaboration with cross-functional partners, the role ensures that resulting clinical evidence is positioned to support regulatory submissions or inform advancement toward broader feasibility or pivotal studies. The role also periodically reviews the portfolio to ensure continued alignment with ONWARD’s strategic priorities and evolving clinical evidence needs. Scientifically grounded in neuroscience, with neuromodulation or spinal cord stimulation experience strongly preferred, the role engages investigators and KOLs as a scientific peer, bringing clinical and scientific depth to shape study priorities and design and partnering closely with Clinical Science on protocol development.
The role represents the Early Research portfolio within the Clinical Research Committee (CRC), providing portfolio-level visibility and scientific input to inform study prioritization and resource allocation. The role also coordinates the clinical publication and presentation strategy and translates study outcomes and external clinical insights into actionable input for Marketing and R&D, helping shape future indication priorities, evidence strategies, and device requirements.
Portfolio Strategy & Regulatory Pathway Assessment
- Partner with Upstream Marketing to translate strategic indication priorities into a coordinated clinical evidence plan that aligns the portfolio of early research (IIS, EFS, grant-funded studies) across ARC-EX, ARC-IM, and ARC-BCI.
- Apply strategic judgment to assess the scientific merit, regulatory pathway, and commercial value of each study opportunity, including partner with Regulatory Affairs to determine how the resulting evidence could support regulatory approval, inform advancement to broader feasibility or pivotal trials, and prioritize or disposition studies accordingly.
- Incorporate input from Market Access on reimbursement and health-economic evidence needs so the portfolio generates data that supports both regulatory approval and market access strategy.
- Periodically review the full early-research portfolio against Marketing's strategic priorities; recommend and drive adjustments, including starting or stopping studies, consolidating single-center studies into multi-center programs, or redirecting resources toward higher-priority indications.
- Identify evidence gaps required for regulatory approval of priority indications and coordinate next steps with Regulatory Affairs, Clinical Science, and Clinical Operations.
- Serve as ONWARD's primary contact with investigators and KOLs across the early-research portfolio, engaging as a scientific peer in study concept, design discussion, and interpretation of results.
- Build and sustain long-term scientific relationships with investigators and institutions, representing ONWARD as a credible scientific partner in the neuromodulation and spinal cord injury community.
- Facilitate engagement between KOLs and Clinical Science to support protocol development and study design, while remaining the primary…
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