# Senior Director, Wound Biologics R&D at Smith+Nephew

Smith+Nephew is hiring a Senior Director, Wound Biologics R&D. Level rates it Little AI ●○○○; you can [apply on Smith+Nephew](https://jobsbylevel.com/go/6f4bb0b2-ca94-46a5-8fc2-50c5f222159a?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Fort Worth.

## Details

- Company: [Smith+Nephew](https://jobsbylevel.com/companies/smith-nephew)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Fort Worth
- Posted: November 13, 2026
- Apply: https://jobsbylevel.com/go/6f4bb0b2-ca94-46a5-8fc2-50c5f222159a?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=senior-director-wound-biologics-r-d-at-smith-nephew-18b3f9

## Description

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Senior Director, Wound Biologics R&D is primarily accountable for leading the R&D activities required to advance one or more clinical-stage wound biologics products. The role works closely with Regulatory Affairs, Quality Assurance, Clinical, and Chemistry, Manufacturing and Controls (CMC), and requires sufficient knowledge across these disciplines to provide integrated leadership for the overall product development program. The leader will align cross-functional activities and guide the product through IND, Phase 1, Phase 2 and Phase 3 development, with progressive registration and commercialization readiness. This role requires direct, practical experience across R&D, clinical development, Chemistry, Manufacturing and Controls (CMC), and Regulatory Affairs. The successful candidate will integrate these disciplines as one development program, lead a matrixed team and provide clear recommendations on evidence, investment, risk, timing and value creation. The role does not replace the Medical Monitor, Regulatory authority, Quality authority or functional CMC owner. It provides the integrated leadership, governance and decision discipline needed to align those accountabilities and deliver the program. What will you be doing? - Lead the integrated development strategy and execution for wound biologics from IND-enabling and IND maintenance activities through Phase 1, Phase 2, Phase 3, marketing-application readiness and lifecycle planning. - Own the cross-functional development roadmap, critical path, stage gates, budget, resource plan, risk register, decision log and executive governance cadence. - Work closely with PMO to integrate R&D, Clinical, Medical, Regulatory, CMC/Technical Operations, Quality, Nonclinical, Biostatistics, Data Management, Manufacturing, Finance, Legal and Commercial inputs into one baselined plan. - Lead internal experts and external partners, including CROs, CDMOs, laboratories, consultants, investigators and scientific advisors, while retaining company ownership of decisions, data and know-how. - Create evidence-based recommendations for investment, indication sequencing, dose and regimen strategy, manufacturing readiness, pivotal development and registration pathways. - Escalate material patient-safety, product-quality, compliance, clinical, regulatory, supply, funding and schedule risks early, with options and recommended actions. 1. Integrated R&D and program leadership - Partner with PMO to define and maintain the integrated development plan, target product profile, milestone baseline, critical path, decision criteria and risk-adjusted scenarios. - Translate scientific, clinical, CMC and regulatory information into clear trade-offs and recommendations for executive governance. - Ensure unresolved assumptions and evidence gaps are explicit, owned and linked to development gates and health-authority questions. - Align indication strategy and development priorities to unmet wound-care needs, intended claims, competitive differentiation, reimbursement considerations and portfolio value. - Build a high-performing matrix team with clear role charters, decision rights, interfaces, escalation paths and closure criteria. 2. Clinical development: Phase 1 through Phase 3 - Partner with Clinical and Medical leadership to shape protocol strategy, dose and regimen selection, endpoints, study populations, safety surveillance and benefit-risk assessment across Phase 1, Phase 2 and Phase 3. - Convert Phase 1 safety, tolerability, pharmacology and early activity findings into defined Phase 2 entry criteria, dose-selection logic and evidence plans. - Use Phase 2 outputs to drive indication and regimen confirmation, endpoint selection, statistical assumptions, pivotal-study design and Phase 3 investment recommendations. - Ensure Phase 3 planning integrates clinical operations, biostatistics, data management,

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/senior-director-wound-biologics-r-d-at-smith-nephew-18b3f9

Source: https://jobsbylevel.com/jobs/senior-director-wound-biologics-r-d-at-smith-nephew-18b3f9

## Cite this page

Level. https://jobsbylevel.com/jobs/senior-director-wound-biologics-r-d-at-smith-nephew-18b3f9.

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